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4. O-10 Trastuzumab with trimodality treatment for esophageal adenocarcinoma with HER2 overexpression: NRG Oncology/RTOG 1010

Author

Ilson, D., primary, Moughan, J., additional, Safran, H., additional, Wigle, D., additional, Depetrillo, T., additional, Haddock, M., additional, Hong, T., additional, Leichman, L., additional, Rajdev, L., additional, Resnick, M., additional, Kachnic, L., additional, Seaward, S., additional, Mamon, H., additional, Pardo, D. Dian, additional, Anderson, C., additional, Shen, X., additional, Sharma, A., additional, Katz, A., additional, Salo, J., additional, Leonard, K., additional, and Crane, C., additional

Published
2020
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12. A phase II/III randomized study to compare the efficacy and safety of rigosertib plus gemcitabine versus gemcitabine alone in patients with previously untreated metastatic pancreatic cancer

Author

O'Neil, B.H., primary, Scott, A.J., additional, Ma, W.W., additional, Cohen, S.J., additional, Leichman, L., additional, Aisner, D.L., additional, Menter, A.R., additional, Tejani, M.A., additional, Cho, J.K., additional, Granfortuna, J., additional, Coveler, L., additional, Olowokure, O.O., additional, Baranda, J.C., additional, Cusnir, M., additional, Phillip, P., additional, Boles, J., additional, Nazemzadeh, R., additional, Rarick, M., additional, Cohen, D.J., additional, Radford, J., additional, Fehrenbacher, L., additional, Bajaj, R., additional, Bathini, V., additional, Fanta, P., additional, Berlin, J., additional, McRee, A.J., additional, Maguire, R., additional, Wilhelm, F., additional, Maniar, M., additional, Jimeno, A., additional, Gomes, C.L., additional, and Messersmith, W.A., additional

Published
2015
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17. Phase I and pharmacologic evaluation of intraperitoneal 5-fluoro-2'-deoxyuridine

Author

Muggia, FM, Chan, KK, Russell, C, Speyer, JL, Sehgal, K, Jeffers, S, Sorich, J, Leichman, L, Beller, U., COLOMBO, NICOLETTA, Muggia, F, Chan, K, Russell, C, Colombo, N, Speyer, J, Sehgal, K, Jeffers, S, Sorich, J, Leichman, L, and Beller, U

Subjects
Time Factor, Dose-Response Relationship, Drug, MED/40 - GINECOLOGIA E OSTETRICIA, Ascitic Fluid, Drug Evaluation, Neoplasm, Humans, Floxuridine, Injections, Intraperitoneal
Abstract

Intraperitoneal (i.p.) 5-fluoro-2'-deoxyuridine (Floxuridine, FUdR, FdUrd) was evaluated in a phase I study at a starting level of 500 mg given on 1 day in 2 I 1.5% dialysate. Escalations within patients were allowed every other cycle. A total of 23 patients (age, 32-78 years) received 108 treatment courses. Local tolerance at all dose levels was excellent, with no cases of drug-related peritonitis being observed. Nausea and vomiting increased in severity in relation to dose and was universal at greater than 3,000 mg x 3 days. One patient each developed grade 1 mucositis as well as diarrhea at a dose of 3,000 mg x 3 days and leukopenia and thrombocytopenia at 5,000 mg x 3 days. Peritoneal fluid (PF) and plasma (PL) FdUrd profiles were monitored by an HPLC method in 13 subjects, with 7 being studied serially at 2-4 increment doses for up to 6 h. Profiles that exhibited apparent linear pharmacokinetics gave PF drug levels 2-4 logs higher than the PL counterparts, with the latter essentially declining in parallel to the former, indicating that the disposition of FdUrd from the peritoneal compartment is rate-determining. The mean terminal half-life for PF FdUrd was found to be 115 min and mean peritoneal clearance was 25 ml/min. The vast differences in drug levels and AUC found between the PF and the PL profiles suggests a high systemic clearance of FdUrd, which was confirmed in two patients receiving 2 g FdUrd by short i.v. infusion. A disproportionate increase in the plasma FdUrd levels and the corresponding AUC values was found with increasing dose, suggesting a disproportionate increase in the systemic partitioning of FdUrd when doses were escalated within a patient. Substantial levels of peritoneal 5-fluorouracil (FUra) were also detected in most of the subjects. Thus, FdUrd was found to have several desirable properties for i.p. administration: (1) a 2- to 4-log pharmacologic advantage. (2) the absence of local toxicities, and (3) a favorable antitumor spectrum and some evidence of antitumor effects in this phase I and pharmacology study. A 3,000-mg dose given in 2 1 1.5% dialysate for 3 consecutive days exhibited antitumor activity and produced no systemic toxicity except nausea and vomiting, which was controlled by antiemetics. This dose schedule is therefore recommended for phase II trials directed against small-volume disease in the peritoneal cavity, such as may be found in some stages of ovarian and gastrointestinal cancers.(ABSTRACT TRUNCATED AT 400 WORDS)

Published
1991

18. A fixed-sequence, open-label study to determine the activity of SCH 717454 (robatumumab) as assessed by positron emission tomography in patients with relapsed or recurrent colorectal cancer.

Author

Lin, E. H., primary, Lenz, H., additional, Saleh, M. N., additional, Badarinath, S., additional, Knost, J. A., additional, MacKenzie, M. J., additional, Polite, B. N., additional, Kavan, P., additional, Chen, E. X., additional, Leichman, L. P., additional, Pathiraja, K., additional, and Lu, B. D., additional

Published
2011
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19. Association of excision repair cross-complementation group 1 (ERCC1) gene expression (GE) with outcome in stage II-III esophageal adenocarcinoma (EA) patients treated with preoperative platinum-based chemoradiation (CRT) in a phase II cooperative group study (SWOG S0356).

Author

Bohanes, P. O., primary, Goldman, B. H., additional, Leichman, L. P., additional, Blanke, C. D., additional, Iqbal, S., additional, Thomas, C. R., additional, Corless, C. L., additional, Billingsley, K. G., additional, Danenberg, K. D., additional, Zhang, W., additional, Benedetti, J. K., additional, Gold, P. J., additional, and Lenz, H., additional

Published
2011
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21. Association of excision repair cross-complementation group 1 (ERCC1) gene expression (GE) with outcome in stage II-III esophageal adenocarcinoma (EA) patients treated with preoperative platinum-based chemoradiation (CRT) in a phase II cooperative study (SWOG 0356).

Author

Bohanes, P. O., primary, Goldman, B. H., additional, Benedetti, J., additional, Blanke, C. D., additional, Leichman, L. P., additional, Iqbal, S., additional, Thomas, C. R., additional, Corless, C. L., additional, Gold, P. J., additional, and Lenz, H., additional

Published
2011
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22. E2205: A phase II study to measure response rate and toxicity of neoadjuvant chemoradiotherapy (CRT) with oxaliplatin (OX) and infusional 5-fluorouracil (5-FU) plus cetuximab (C) followed by postoperative docetaxel (DT) and C in patients with operable adenocarcinoma of the esophagus.

Author

Gibson, M. K., primary, Catalano, P. J., additional, Kleinberg, L., additional, Staley, C. A., additional, Montgomery, E., additional, Song, W., additional, Mulcahy, M. F., additional, Leichman, L. P., additional, and Benson, A. B., additional

Published
2010
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23. Oxaliplatin (OXP) plus protracted infusion 5-fluorouracil (PIFU) and external beam radiation (EBRT) prior to surgery (S) for potentially curable esophageal adenocarcinoma (EA): A Southwest Oncology Group (SWOG) phase II trial with molecular correlates (S0356)

Author

Leichman, L., primary, Goldman, B. H., additional, Benedetti, J. K., additional, Billingsley, K. G., additional, Thomas, C. R., additional, Iqbal, S., additional, Lenz, H., additional, Blanke, C., additional, Gold, P. J., additional, and Corless, C. L., additional

Published
2009
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24. Expression of Genes Related to Activity of Oxaliplatin and 5-Fluorouracil in Endoscopic Biopsies of Primary Esophageal Cancer in Patients Receiving Oxaliplatin, 5-Flourouracil and Radiation: Characterization and Exploratory Analysis with Survival

Author

Leichman, L., primary, Lawrence, D., additional, Leichman, C.G., additional, Nava, H., additional, Nava, E., additional, Proulx, G., additional, Clark, K., additional, Khushalani, N.I., additional, Berdzik, J., additional, Greco, W., additional, Smith, P., additional, Creaven, P.J., additional, Kepner, J.L., additional, Javle, M.M., additional, and Pendyala, L., additional

Published
2006
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28. Phase I and pharmacologic evaluation of intraperitoneal 5-fluoro-2'-deoxyuridine

Author

Muggia, F, Chan, K, Russell, C, Colombo, N, Speyer, J, Sehgal, K, Jeffers, S, Sorich, J, Leichman, L, Beller, U, Muggia, FM, Chan, KK, Speyer, JL, Beller, U., COLOMBO, NICOLETTA, Muggia, F, Chan, K, Russell, C, Colombo, N, Speyer, J, Sehgal, K, Jeffers, S, Sorich, J, Leichman, L, Beller, U, Muggia, FM, Chan, KK, Speyer, JL, Beller, U., and COLOMBO, NICOLETTA

Abstract

Intraperitoneal (i.p.) 5-fluoro-2'-deoxyuridine (Floxuridine, FUdR, FdUrd) was evaluated in a phase I study at a starting level of 500 mg given on 1 day in 2 I 1.5% dialysate. Escalations within patients were allowed every other cycle. A total of 23 patients (age, 32-78 years) received 108 treatment courses. Local tolerance at all dose levels was excellent, with no cases of drug-related peritonitis being observed. Nausea and vomiting increased in severity in relation to dose and was universal at greater than 3,000 mg x 3 days. One patient each developed grade 1 mucositis as well as diarrhea at a dose of 3,000 mg x 3 days and leukopenia and thrombocytopenia at 5,000 mg x 3 days. Peritoneal fluid (PF) and plasma (PL) FdUrd profiles were monitored by an HPLC method in 13 subjects, with 7 being studied serially at 2-4 increment doses for up to 6 h. Profiles that exhibited apparent linear pharmacokinetics gave PF drug levels 2-4 logs higher than the PL counterparts, with the latter essentially declining in parallel to the former, indicating that the disposition of FdUrd from the peritoneal compartment is rate-determining. The mean terminal half-life for PF FdUrd was found to be 115 min and mean peritoneal clearance was 25 ml/min. The vast differences in drug levels and AUC found between the PF and the PL profiles suggests a high systemic clearance of FdUrd, which was confirmed in two patients receiving 2 g FdUrd by short i.v. infusion. A disproportionate increase in the plasma FdUrd levels and the corresponding AUC values was found with increasing dose, suggesting a disproportionate increase in the systemic partitioning of FdUrd when doses were escalated within a patient. Substantial levels of peritoneal 5-fluorouracil (FUra) were also detected in most of the subjects. Thus, FdUrd was found to have several desirable properties for i.p. administration: (1) a 2- to 4-log pharmacologic advantage. (2) the absence of local toxicities, and (3) a favorable antitumor spectrum an

Published
1991

29. ERCC1 mRNA levels complement thymidylate synthase mRNA levels in predicting response and survival for gastric cancer patients receiving combination cisplatin and fluorouracil chemotherapy.

Author

Metzger, R, primary, Leichman, C G, additional, Danenberg, K D, additional, Danenberg, P V, additional, Lenz, H J, additional, Hayashi, K, additional, Groshen, S, additional, Salonga, D, additional, Cohen, H, additional, Laine, L, additional, Crookes, P, additional, Silberman, H, additional, Baranda, J, additional, Konda, B, additional, and Leichman, L, additional

Published
1998
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34. Quantitation of intratumoral thymidylate synthase expression predicts for resistance to protracted infusion of 5-fluorouracil and weekly leucovorin in disseminated colorectal cancers: Preliminary report from an ongoing trial

Author

Leichman, L, primary, Lenz, H.-J, additional, Leichman, C.G, additional, Groshen, S, additional, Danenberg, K, additional, Baranda, J, additional, Spears, C.P, additional, Boswell, W, additional, Silberman, H, additional, Ortega, A, additional, Stain, S, additional, Beart, R, additional, and Danenberg, P, additional

Published
1995
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39. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group.

Author

Cooper, J S, Guo, M D, Herskovic, A, Macdonald, J S, Martenson, J A Jr, Al-Sarraf, M, Byhardt, R, Russell, A H, Beitler, J J, Spencer, S, Asbell, S O, Graham, M V, and Leichman, L L

Abstract

Context: Carcinoma of the esophagus traditionally has been treated by surgery or radiation therapy (RT), but 5-year overall survival rates have been only 5% to 10%. We previously reported results of a study conducted from January 1986 to April 1990 of combined chemotherapy and RT vs RT alone when an interim analysis revealed significant benefit for combined therapy.Objective: To report the long-term outcomes of a previously reported trial designed to determine if adding chemotherapy during RT improves the survival rate of patients with esophageal carcinoma.Design: Randomized controlled trial conducted 1985 to 1990 with follow-up of at least 5 years, followed by a prospective cohort study conducted between May 1990 and April 1991.Setting: Multi-institution participation, ranging from tertiary academic referral centers to general community practices.Patients: Patients had squamous cell or adenocarcinoma of the esophagus, T1-3 N0-1 M0, adequate renal and bone marrow reserve, and a Karnofsky score of at least 50. Interventions Combined modality therapy (n = 134): 50 Gy in 25 fractions over 5 weeks, plus cisplatin intravenously on the first day of weeks 1, 5, 8, and 11, and fluorouracil, 1 g/m2 per day by continuous infusion on the first 4 days of weeks 1, 5, 8, and 11. In the randomized study, combined therapy was compared with RT only (n = 62): 64 Gy in 32 fractions over 6.4 weeks.Main Outcome Measures: Overall survival, patterns of failure, and toxic effects.Results: Combined therapy significantly increased overall survival compared with RT alone. In the randomized part of the trial, at 5 years of follow-up the overall survival for combined therapy was 26% (95% confidence interval [CI], 15%-37%) compared with 0% following RT. In the succeeding nonrandomized part, combined therapy produced a 5-year overall survival of 14% (95% CI, 6%-23%). Persistence of disease (despite therapy) was the most common mode of treatment failure; however, it was less common in the groups receiving combined therapy (34/130 [26%]) than in the group treated with RT only (23/62 [37%]). Severe acute toxic effects also were greater in the combined therapy groups. There were no significant differences in severe late toxic effects between the groups. However, chemotherapy could be administered as planned in only 89 (68%) of 130 patients (10% had life-threatening toxic effects with combined therapy vs 2% in the RT only group).Conclusion: Combined therapy increases the survival of patients who have squamous cell or adenocarcinoma of the esophagus, T1-3 N0-1 M0, compared with RT alone. [ABSTRACT FROM AUTHOR]

Published
1999
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46. Phase I and pharmacologic evaluation of intraperitoneal 5-fluoro-2'-deoxyuridine.

Author

Muggia, Franco, Chan, Kenneth, Russell, Christy, Colombo, Nicoletta, Speyer, James, Sehgal, Kishore, Jeffers, Susan, Sorich, Joan, Leichman, Lawrence, Beller, Uziel, Beckman, E., Muggia, F M, Chan, K K, Russell, C, Colombo, N, Speyer, J L, Sehgal, K, Jeffers, S, Sorich, J, and Leichman, L

Subjects
BODY fluids, COMPARATIVE studies, DOSE-effect relationship in pharmacology, CLINICAL drug trials, INJECTIONS, RESEARCH methodology, MEDICAL cooperation, RESEARCH, TIME, TUMORS, EVALUATION research, FLUORODEOXYURIDINE, PHARMACODYNAMICS
Abstract

Intraperitoneal (i.p.) 5-fluoro-2'-deoxyuridine (Floxuridine, FUdR, FdUrd) was evaluated in a phase I study at a starting level of 500 mg given on 1 day in 2 I 1.5% dialysate. Escalations within patients were allowed every other cycle. A total of 23 patients (age, 32-78 years) received 108 treatment courses. Local tolerance at all dose levels was excellent, with no cases of drug-related peritonitis being observed. Nausea and vomiting increased in severity in relation to dose and was universal at greater than 3,000 mg x 3 days. One patient each developed grade 1 mucositis as well as diarrhea at a dose of 3,000 mg x 3 days and leukopenia and thrombocytopenia at 5,000 mg x 3 days. Peritoneal fluid (PF) and plasma (PL) FdUrd profiles were monitored by an HPLC method in 13 subjects, with 7 being studied serially at 2-4 increment doses for up to 6 h. Profiles that exhibited apparent linear pharmacokinetics gave PF drug levels 2-4 logs higher than the PL counterparts, with the latter essentially declining in parallel to the former, indicating that the disposition of FdUrd from the peritoneal compartment is rate-determining. The mean terminal half-life for PF FdUrd was found to be 115 min and mean peritoneal clearance was 25 ml/min. The vast differences in drug levels and AUC found between the PF and the PL profiles suggests a high systemic clearance of FdUrd, which was confirmed in two patients receiving 2 g FdUrd by short i.v. infusion. A disproportionate increase in the plasma FdUrd levels and the corresponding AUC values was found with increasing dose, suggesting a disproportionate increase in the systemic partitioning of FdUrd when doses were escalated within a patient. Substantial levels of peritoneal 5-fluorouracil (FUra) were also detected in most of the subjects. Thus, FdUrd was found to have several desirable properties for i.p. administration: (1) a 2- to 4-log pharmacologic advantage. (2) the absence of local toxicities, and (3) a favorable antitumor spectrum and some evidence of antitumor effects in this phase I and pharmacology study. A 3,000-mg dose given in 2 1 1.5% dialysate for 3 consecutive days exhibited antitumor activity and produced no systemic toxicity except nausea and vomiting, which was controlled by antiemetics. This dose schedule is therefore recommended for phase II trials directed against small-volume disease in the peritoneal cavity, such as may be found in some stages of ovarian and gastrointestinal cancers.(ABSTRACT TRUNCATED AT 400 WORDS) [ABSTRACT FROM AUTHOR]

Published
1991
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47. Biological modification of protracted infusion of 5-fluorouracil with weekly leucovorin. A dose seeking clinical trial for patients with disseminated gastrointestinal cancers.

Author

Leichman, C G, Leichman, L, Spears, C P, Rosen, P J, Muggia, F, Jeffers, S, and Waugh, W

Subjects
METASTASIS, ANTINEOPLASTIC agents, CLINICAL trials, COMPARATIVE studies, DRUG administration, CLINICAL drug trials, FLUOROURACIL, FOLINIC acid, RESEARCH methodology, MEDICAL cooperation, RESEARCH, RESEARCH funding, TUMOR antigens, GASTROINTESTINAL tumors, EVALUATION research, PREVENTION
Abstract

A clinical trial was designed to find the maximally tolerated dose of weekly leucovorin (LV) that could be combined with 4 weeks of protracted infusion (PI) of 5-fluorouracil (5FU) at a fixed dose of 200 mg/m2. A total of 36 patients with disseminated gastrointestinal malignancies were treated; 9 either progressed or died before receiving 4 weeks of treatment leaving 27 patients evaluable for toxicity and response. 5FU was given as a protracted infusion using an ambulatory infusion pump and indwelling venous access. LV doses included 20, 25, 50, and 75 mg/m2 given as an i.v. push at the time of weekly pump fill with 5FU. In all, 72% of the patients tolerated LV at 20 mg/m2 for 4 continuous weeks, whereas the higher doses required treatment rests prior to 4 weeks. The dose-limiting toxicity at all doses was stomatitis. No significant myelosuppression was seen; diarrhea was infrequent. Overall, 40% of the patients with measurable cancer had partial responses. In view of evidence of biologic and therapeutic effects of these weekly doses of 20 mg/m2 LV with 200 mg/m2 5FU per day given as a protracted infusion over 4 weeks, phase II trials and multimodality studies for patients with gastrointestinal malignancies are being initiated at our institution using this dose and schedule. [ABSTRACT FROM AUTHOR]

Published
1990

48. Eradication and palliation of squamous cell carcinoma of the esophagus with chemotherapy, radiotherapy, and surgical therapy

Author

Steiger, Z., Franklin, R., Wilson, R.F., Leichman, L., Seydel, H., Loh, J.J.K., Vaishamapayan, G., Knechtges, T., Asfaw, I., Dindogru, A., Rosenberg, J.C., Buroker, T., Torres, A., Hoschner, D., Miller, P., Pietruk, T., and Vaitkevicius, V.

Abstract

Between April, 1977, and March, 1981, 86 unselected patients with proved squamous cell carcinoma of the esophagus were treated with a combination of chemotherapy and radiotherapy followed by operation whenever feasible. The preoperative chemotherapeutic agents used initially were 5-fluorouracil, and mitomycin C. After December, 1979, cis-platinum was used instead of mitomycin C. Radiotherapy (3,000 rads) of the tumor was begun at the same time as the chemotherapy. An esophagectomy was performed on suitable candidates 3 to 4 weeks after the chemotherapy and radiotherapy were completed. The mucosal lesion disappeared in 69 of the 86 patients, and dysphagia was relieved at least temporarily in 57 of 62 patients. Recurrent dysphagia resulting from fibrosis at the tumor site caused a secondary stenosis in 11 patients. Excellent palliation was obtained in five patients with bronchoesophageal fistulas who had an initial substernal gastric bypass followed by chemotherapy and radiotherapy. Of the 48 patients who had an esophagectomy, 15 (31%) had no tumor in the resected specimen. Eleven of these 15 patients are still alive with no evidence of disease. All patients with a lesion less than 5.0 cm in length had complete regression of the tumor. We believe that this combination of chemotherapy, radiotherapy, and surgical therapy provides excellent palliation, increases resectability, and has a potential for cure.

Published
1981
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