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Home > "A" Clinical Trials Conditions > Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus  Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
For Condition: stage 3 gastric cancer,recurrent esophageal cancer,adenocarcinoma of the stomach,stage 3 esophageal cancer,stage 4 esophageal cancer,recurrent gastric cancer,stage 4 gastric cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with locally advanced, metastatic, or recurrent cancer of the stomach or esophagus.
Details: OBJECTIVES: I. Determine the objective response rate of a 120 hour continuous infusion of aminocamptothecin (9-AC) in chemotherapy naive patients with adenocarcinoma of the stomach or gastroesophageal junction. II. Characterize the nature of the toxicity of 9-AC on this schedule in this patient population. III. Determine the duration of response, time to progression, and survival of this patient population. IV. Study the pharmacokinetics and pharmacodynamics of 9-AC on this schedule in these patients. PROTOCOL OUTLINE: This is an open label, multicenter study. Patients receive intravenous aminocamptothecin by continuous infusion over 120 hours on days 1-5 and 8-12 followed by 1 week of rest for a 3 week cycle. Therapy continues for a minimum of 6 weeks (2 full cycles) unless there are unacceptable toxic effects or rapid disease progression. Dose escalation may occur in patients who complete 3 cycles of therapy without unacceptable toxicity. All patients will be followed for survival. PROJECTED ACCRUAL: This study will accrue 14-40 patients within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed, locally advanced, metastatic or recurrent adenocarcinoma of the stomach or gastroesophageal junction - Measurable disease - CNS metastases allowed provided that patient has other sites of measurable disease, is neurologically stable, and is receiving no concurrent anticonvulsant therapy --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent prophylactic growth factors - Chemotherapy: One prior adjuvant or neoadjuvant 5-FU-based chemotherapy regimen allowed; At least 4 weeks since prior adjuvant or neoadjuvant chemotherapy (6 weeks if nitrosoureas or mitomycin) and recovered; No prior therapy with a topoisomerase I inhibitor ;No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: One prior radiotherapy regimen allowed; No prior radiation therapy to only site of measurable disease; At least 4 weeks since prior radiation therapy and recovered; No concurrent palliative radiation therapy - Surgery: Not specified - Other: See Disease Characteristics; No other concurrent investigational antineoplastic therapy --Patient Characteristics-- - Age: 18 and over - Performance status: CALGB 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3500/mm3; Absolute neutrophil count at least 1500/mm3; Platelet count at least 100,000/mm3 (no platelet transfusion within 7 days); Hemoglobin at least 9 g/dL - Hepatic: Total bilirubin no greater than 1.5 mg/dL; Transaminases no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases) - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No concurrent uncontrolled medical or psychiatric condition; No active uncontrolled infection; No prior malignant disease within the past 5 years except curatively treated non-melanoma skin cancer and carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HedyKindler, Study Chair, University of Chicago Cancer Research Center
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Additional Information:
Study ID Numbers: CDR0000066026; UCCRC-9025,NCI-T97-0013
Study Start Date: January 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003192
Other Recurrent Gastric Cancer Studies:
1. Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
2. Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
3. Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
4. Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach
5. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
Related Studies:
Other recurrent gastric cancer Clinical Trials
Other Indiana Clinical Trials
Other Ft. Wayne Clinical Trials
Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
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