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4. PB1737 MULTICENTER, RANDOMIZED, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE AND FOOD EFFECT ON THE BIOAVAILABILITY OF CC-486 (ORAL AZACITIDINE) TABLETS IN ADULT CANCER PATIENTS

Author

Babiker, H., primary, Milhem, M., additional, Aisner, J., additional, Edenfield, W., additional, Shepard, D., additional, Savona, M., additional, Iyer, S., additional, Abdelrahim, M., additional, Lam, D., additional, Laille, E., additional, Fei Li, Y., additional, Tsai, K.-T., additional, and Ho, T., additional

Published
2019
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7. Daily Image-Guidance with Cone Beam Computed Tomography May Reduce Radiation Pneumonitis in Unresectable Non-Small Cell Lung Cancer

Author

Yegya-Raman, N., primary, Kim, S., additional, Deek, M.P., additional, Li, D., additional, Gupta, A., additional, Bond, L., additional, Dwivedi, A.P., additional, Braver, J.K., additional, Reyhan, M., additional, Mittal, A., additional, Gui, B., additional, Malhotra, J., additional, Aisner, J., additional, and Jabbour, S.K., additional

Published
2018
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14. Clinical Characteristics and Dose Volume Histogram Parameters Associated With Pleural Effusion in Non-Small Cell Lung Cancer Patients Treated With Chemoradiation Therapy

Author

Deek, M.P., primary, Nagarajan, S., additional, Kim, S., additional, Ahmed, I., additional, Paul, S., additional, Scher, E.D., additional, Listo, M., additional, Chen, A., additional, Aisner, J., additional, Hussain, S., additional, Haffty, B.G., additional, and Jabbour, S.K., additional

Published
2015
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18. 2879 High prevalent BRAF alterations and tert promoter mutations in papillary thyroid carcinoma

Author

Wang, K., primary, Ganesan, S., additional, Johnson, A., additional, Sharman, J.P., additional, Chachoua, A., additional, Hirshfield, K., additional, Aisner, J., additional, Yelensky, R., additional, Lipson, D., additional, Elvin, J.A., additional, Chmielecki, J., additional, Stephens, P.J., additional, Ross, J.S., additional, Miller, V.A., additional, Ou, S.H.I., additional, and Ali, S.M., additional

Published
2015
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23. Chemoradiotherapy in non-small cell lung cancer: paclitaxel/carboplatin/radiotherapy in regionally advanced disease

Author

Chandra Belani, Aisner J, Bahri S, Jett J, Day R, Mj, Capazolli, Hiponia D, and Engstrom C

Subjects
Adult, Radiation-Sensitizing Agents, Lung Neoplasms, Mucous Membrane, Neutropenia, Paclitaxel, Middle Aged, Antineoplastic Agents, Phytogenic, Combined Modality Therapy, Drug Administration Schedule, Carboplatin, Survival Rate, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Esophagitis, Humans, Aged
Abstract

Based on superior results observed with combined-modality therapy over radiotherapy alone and on the authors' previous work with carboplatin and standard daily thoracic radiotherapy in patients with advanced, unresectable non-small cell lung cancer, a phase II study was designed to incorporate radiosensitizing doses of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) into the carboplatin/radiotherapy regimen, to improve the therapeutic index and define the toxicities. Thirty-two patients have been entered. Paclitaxel 45 mg/m2/wk was administered over 3 hours prior to carboplatin (100 mg/m2/wk) and thoracic radiotherapy (1.8 Gy/d 5 days a week; total dose, 60 to 65 Gy). No grade 4 toxicities occurred. Seven patients had chemotherapy doses delayed because of grade 3 neutropenia, and one patient had grade 3 mucositis/esophagitis that required hospitalization. Median survival has not yet been reached, and all patients are being followed. These preliminary data demonstrate the feasibility of combined concurrent chemoradiotherapy, with acceptable toxicities. Further investigation is needed to optimize carboplatin dosage with adaptive control using formulas based on pharmacokinetics and pharmacodynamics. Full-dose induction chemotherapy regimens to maximize the systemic effects of chemotherapy should precede concurrent chemoradiotherapy in future studies.

Published
1996

24. Paclitaxel and carboplatin in metastatic non-small cell lung cancer: preliminary results of a phase I study

Author

Chandra Belani, Aisner J, Hiponia D, and Ramanathan R

Subjects
Lung Neoplasms, Filgrastim, Paclitaxel, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, Humans, Drug Administration Schedule, Recombinant Proteins, Carboplatin
Abstract

Given their known activity against non-small cell lung cancer, paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin were combined in this phase I study of patients with metastatic disease to determine the maximum tolerated dose and the dose-limiting toxicity of the combination. The initial dose of paclitaxel was fixed at 135 mg/m2 given as a 24-hour infusion with carboplatin administered in escalating doses in cohorts using Calvert's formula-dose (mg) = target AUC x (GFR + 25), where AUC is area under the concentration-time curve and GFR is glomerular filtration rate-based on target AUCs of 5, 7, 9, or 11 mg/mL.min. Dose escalations were based on cycle 1 toxicities. Filgrastim was not administered with the first cycle until two or more patients developed grade 4 or febrile neutropenia at the preceding dose level. Dose-limiting toxicity occurred in two patients at level 2 (cycle 1), and filgrastim was administered thereafter for the next four dose levels. Grade 4 thrombocytopenia was seen at level 4; thus, the carboplatin dose was de-escalated thereafter, and the paclitaxel dose escalated. Rare nonhematologic toxicities include fatigue, diarrhea, and nausea and vomiting. Among the first 30 patients, one had a complete response and 14 had partial responses, for an overall response rate of 50%. The combination of paclitaxel and carboplatin is active in non-small cell lung cancer, and the recommended phase II dose without filgrastim support is paclitaxel 175 mg/m2 via a 24-hour infusion with the carboplatin dose targeted to achieve an AUC of 7 mg/ mL.min.

Published
1996

25. Feasibility and pharmacokinetics of paclitaxel, carboplatin, and concurrent radiotherapy for regionally advanced squamous cell carcinoma of the head and neck and for regionally advanced non-small cell lung cancer

Author

Aisner J, Chandra Belani, Kearns C, Conley B, Hiponia D, Engstrom C, Zuhowski E, and Mj, Egorin

Subjects
Male, Lung Neoplasms, Paclitaxel, Radiotherapy Dosage, Combined Modality Therapy, Drug Administration Schedule, Carboplatin, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Squamous Cell, Feasibility Studies, Humans, Female, Karnofsky Performance Status
Abstract

Sequential chemotherapy and radiotherapy offer considerable improvements in the care of patients with locally advanced non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). Improved survival for lung cancer and organ preservation in head and neck cancer have occurred with this approach, but local control remains a problem. Concurrent chemotherapy and radiotherapy can potentially improve both local control and control of micrometastases. We previously showed that concurrent carboplatin plus radiotherapy is a useful potential treatment for advanced NSCLC and SCCHN, producing good local control and acceptable toxicity. Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has recently demonstrated strong single-agent activity against both NSCLC and SCCHN. Paclitaxel has also shown favorable interactions with radiotherapy and with platinum compounds. We therefore added weekly paclitaxel at 45 mg/m2 given after premedication and before carboplatin (100 mg/m2) weekly during concurrent standard-dose radiotherapy. Twenty patients (seven with SCCHN and 13 with NSCLC) have been treated (38 and 73 weekly doses, respectively). Toxicities have been manageable with delay or dose reduction in five and eight patients, respectively, for SCCHN and NSCLC. Based on these toxicities paclitaxel dose has been reduced to 40 mg/m2/wk. Plasma pharmacokinetics have shown that concurrent carboplatin and radiotherapy do not alter the pharmacokinetic behavior of paclitaxel compared with single-agent data. Concurrent therapy with carboplatin, paclitaxel, and radiotherapy is feasible on this schedule. Further case accrual to assess efficacy is ongoing.

Published
1995

26. Paclitaxel and carboplatin with and without filgrastim support in patients with metastatic non-small cell lung cancer

Author

Chandra Belani, Aisner J, Hiponia D, and Engstrom C

Subjects
Lung Neoplasms, Neutropenia, Dose-Response Relationship, Drug, Filgrastim, Paclitaxel, Remission Induction, Drug Tolerance, Thrombocytopenia, Recombinant Proteins, Carboplatin, Cohort Studies, Clinical Trials, Phase II as Topic, Carcinoma, Non-Small-Cell Lung, Creatinine, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, Humans, Infusions, Intravenous, Glomerular Filtration Rate
Abstract

Paclitaxel (Taxol; Bristol-Myers Squibb Oncology, Princeton, NJ) and carboplatin have each shown activity against non-small cell lung cancer and they are synergistic in vitro. We thus designed a phase I study to define the maximum tolerated dose and dose-limiting toxicity of the combination with and without filgrastim support. With an initial fixed dose of paclitaxel 135 mg/m2 given as a 24-hour infusion, carboplatin was administered in escalating doses in cohorts of three patients, based on a target area under the concentration-time curve (AUC) of 5, 7, 9, or 11 using Calvert's formula: dose (mg) = target AUC x (glomerular filtration rate + 25). Dose escalations were based on course I toxicities. Filgrastim 5 micrograms/kg was administered with the first cycle only after grade 4 neutropenia occurred in two of three patients at the prior dose level. One hundred five courses of paclitaxel and carboplatin have been administered in 26 patients. Dose-limiting toxicity (grade 4 neutropenia) occurred in two patients at level 2 (cycle I). Filgrastim was instituted thereafter with cycle I for the next four levels. Grade 4 thrombocytopenia was seen at level 4; thus, the carboplatin dose was de-escalated in the next level, but the paclitaxel dose was escalated. The regimen has been well tolerated. One patient had a complete response and 12 had partial responses, for an overall response rate of 50%. There is a suggestion of a dose-response effect with both paclitaxel and carboplatin. The combination of paclitaxel and carboplatin is active in non-small cell lung cancer, and the recommended phase II doses for the combination without filgrastim support are paclitaxel 175 mg/m2 as a 24-hour infusion with the carboplatin dose based on a target AUC of 7. The phase II dose with filgrastim support will be defined as dose escalation of paclitaxel continues.

Published
1995

27. Is there a therapeutic benefit for patients participating in modern phase I trials?

Author

Stein, M. N., primary, Tan, A. R., additional, Mehnert, J. M., additional, Gibbon, D., additional, DiPaola, R. S., additional, Moss, R. A., additional, Poplin, E., additional, Rubin, E. H., additional, Saraiya, B., additional, Kane, M. P., additional, Scott, P., additional, LaRosiliere, M., additional, Camisa, H., additional, Kirin, P., additional, Thomas, C. M., additional, and Aisner, J., additional

Published
2011
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30. Autophagy as a therapeutic target in cancer treatment.

Author

Karantza, V., primary, Moss, R. A., additional, Mehnert, J. M., additional, Stein, M. N., additional, Poplin, E., additional, Saraiya, B., additional, Aisner, J., additional, Tan, A. R., additional, White, E., additional, and DiPaola, R. S., additional

Published
2010
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38. A phase I/II study of high-dose megestrol acetate in the treatment of metastatic breast cancer

Author

Howard L. Parnes, Tchekmedyian Ns, Abrams Js, Aisner J, and Tait N

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Breast Neoplasms, Gastroenterology, Metastasis, chemistry.chemical_compound, Breast cancer, Internal medicine, Medicine, Medroxyprogesterone acetate, Humans, Neoplasm Metastasis, Aged, Dose-Response Relationship, Drug, business.industry, Cancer, Megestrol, Middle Aged, medicine.disease, Metastatic breast cancer, Surgery, Treatment Outcome, Oncology, chemistry, Tolerability, Megestrol acetate, Female, business, medicine.drug
Abstract

A dose-response relationship has been suggested for medroxyprogesterone acetate in the treatment of advanced breast cancer. To determine the tolerability and efficacy of increasing doses of megestrol acetate in the treatment of metastatic breast cancer, we conducted a phase I/II study among 57 patients. Three patients each received 480, 800, and 1280 mg/d; 48 patients received 1600 mg/d. Of the 57 patients, 56 patients had had disease progression on prior hormone therapy, chemotherapy, or both. Twenty-seven patients had previously received standard-dose MA (160 mg/d). Among the 37 patients with measurable disease, high-dose megestrol acetate (HDMA) produced 6 (16%) complete responses (CRs) and 6 (16%) partial responses (PRs); 11 patients achieved stable disease (SD). HDMA resulted in improvement or stabilization in 12 of the 20 patients with evaluable, non-measurable disease. There were no responses among the 6 patients with liver metastases. Among the 27 patients who were previously treated with standard-dose MA, including 9 patients with primary treatment failure, HDMA resulted in 1 CR, 3 PRs, and 10 SD. Toxicities, which were mild and reversible, included fluid retention, hypertension, hyperglycemia, and mild congestive heart failure. Two patients had superficial phlebitis. The most profound side effect was weight gain which occurred in 43 patients (75%). This study suggests a dose-response relationship for MA in the treatment of advanced breast cancer. A randomized trial to determine the optimal dose is ongoing.

Published
1991

44. European School of Oncology. First Euro-American Forum on Lung Cancer Treatment.

Author

UCL - (SLuc) Unité d'oncologie médicale, Bunn, P A, Van Zandwijk, N, Pastorino, U, Aisner, J, Alberto, P, Arriagada, R, Carney, D, Cornis, R, Dittrich, C, Gatzemeier, U, Ginsberg, R., Greco, FA, Hansen, HH, Harper, P., Henriksson, R., Huber, H., Klener, P., Lechevalier, T., Lewensohn, R., Murray, N., Niederle, N., Postmus, P., Rosell, R., Scagliotti, G., Sculier, JP, Splinter, T., Stahel, R., Symann, Michel, Thatcher, N., Tonato, M., Turrisi, A., UCL - (SLuc) Unité d'oncologie médicale, Bunn, P A, Van Zandwijk, N, Pastorino, U, Aisner, J, Alberto, P, Arriagada, R, Carney, D, Cornis, R, Dittrich, C, Gatzemeier, U, Ginsberg, R., Greco, FA, Hansen, HH, Harper, P., Henriksson, R., Huber, H., Klener, P., Lechevalier, T., Lewensohn, R., Murray, N., Niederle, N., Postmus, P., Rosell, R., Scagliotti, G., Sculier, JP, Splinter, T., Stahel, R., Symann, Michel, Thatcher, N., Tonato, M., and Turrisi, A.

Published
1994

45. Psychologic and neuropsychologic functioning of patients with limited small-cell lung cancer treated with chemotherapy and radiation therapy with or without warfarin: a study by the Cancer and Leukemia Group B.

Author

Ahles, T A, primary, Silberfarb, P M, additional, Herndon, J, additional, Maurer, L H, additional, Kornblith, A B, additional, Aisner, J, additional, Perry, M C, additional, Eaton, W L, additional, Zacharski, L L, additional, Green, M R, additional, and Holland, J C, additional

Published
1998
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