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Byline: J. Philip Kuebler (1), Timothy Moore (1), James Pritchard (1), Eric Kraut (2) Keywords: prostate carcinoma; CI-958 Abstract: A phase II trial of CI-958 (NSC #635371), a new benzothiopyranoindazole was performed in patients with hormone refractory prostate carcinoma using prostate specific antigen (PSA) levels for response assessment. Twenty-two patients were entered on this study and twenty one were eligible. Toxicity consisted mainly of granulocytopenia (71% grade 3 or 4), but there were no significant infections. Two patients were removed from study due to asymptomatic decreases in cardiac ejection fraction. Of 21 evaluable patients, there were four responders (19%, CI 0--35%). Author Affiliation: (1) Grant/Riverside Hospitals, Columbus, Ohio, U.S.A (2) The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, U.S.A Article History: Registration Date: 21/10/2004

Byline: Wolfram E. Samlowski (1), Holly Gundacker (2), J. Philip Kuebler (3), Jeffrey K. Giguere (4), Glenn M. Mills (5), David E. Schuller (6), John F. Ensley (7) Keywords: gemcitabine; squamous cell carcinoma; phase II trial Abstract: A phase II trial of gemcitabine(Gemzar(r)), a nucleoside analogue with broadactivity in solid tumors, was performed inpatients with recurrent or metastaticsquamous cell carcinoma of the head andneck. A total of 26 eligible patients wereregistered to receive a dose of1250 mg/m.sup.2 weekly for 3 weeks,followed by a 1 week rest. Toxicity wasevaluable in 26 patients. Nausea andvomiting occured in 11 and 6 patients,repectively. Grade 3 or 4 hematologictoxicities were infrequent. Two patientsdeveloped neutropenic infections. Onepatient developed fatal liver failure whichwas thought due to progressive livermetastases or infection 14 days after asingle dose of gemcitabine. There were noobjective treatment responses (95% CI0--13%), with a median survival of 6 monthsin this highly resistant diseasepopulation. Gemcitabine is not consideredactive enough as monotherapy for furtherevaluation in this disease population. Author Affiliation: (1) Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, U.S.A. (2) Southwest Oncology Group Statistical Center, Seattle, WA, U.S.A. (3) Columbus CCOP, Columbus, OH, U.S.A. (4) Greenville CCOP, Greenville, SC, U.S.A. (5) Louisiana State University Medical Center, Shreveport, LA, U.S.A. (6) Ohio State University Health Center, Columbus, OH, U.S.A. (7) Wayne State University Medical Center, Detroit, MI, U.S.A. Article History: Registration Date: 11/10/2004

Byline: John S. Macdonald (1), Joth L. Jacobson (2), Steven J Ketchel (3), Geoffrey Weiss (4), Sarah Taylor (5), Glenn Mills (6), J. Phillip Kuebler (7), Saul Rivkin (8), Marcel Conrad (9) Keywords: esophageal cancer; gastrointestinal cancer; topotecan; topoisomerase-1 inhibitor Abstract: Background. Chemotherapeutic treatments containingtopoisomerase I inhibitors have shown antitumor activity against anumber of solid tumors. Responses have been seen in Phase I trialsusing topotecan in ovarian, lung, and esophageal cancer. A phase II trial using continuous infusion topotecan was completed toassess activity in esophagus cancer. Methods. Forty-fiveeligible patients with locally-advanced or metastatic squarnouscell carcinoma or adenocarcinoma of the esophagus received a regimen consisting of 24-hour continuous infusion topotecan at 1.5mg/m.sup.2/day on Days 1, 8, 15, 22 (of 42-day cycle). Patientscontinued on treatment until evidence of disease progression orunacceptable toxicity. Results. Partial response was demonstrated in 1 patient (2% confirmed response rate). Thirty-sixpatients progressed during the first cycle of treatment. The mediansurvival was 3 months, and the median progression-free survival was1 month. Toxicity was mild with only one Grade 4 toxicity reported.Conclusions. This phase II trial indicates nosignificant anti-neoplastic activity for topotecan administered inthe dose and schedule to patients with squamous cell oradenocarcinoma of the esophagus. Author Affiliation: (1) Saint Vincents Comprehensive Cancer Center, New York, NY (2) Southwest Oncology Group Statistical Center, Seattle, WA (3) Cancer Care Center of Southern Arizona, Tucson, AZ (4) Division of Medical Oncology, UT Health Science Center, San Antonio, TX (5) Veterans Administration Hospital, Kansas City, MO (6) LSU Medical Center, Shreveport, LA (7) Cancer Services, Columbus, OH (8) Tumor Institute of Swedish Hospital Medical Center, Seattle, WA (9) University of Southern Alabama, Mobile, AL, USA Article History: Registration Date: 09/10/2004