Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
NCT ID: NCT00003192
Last Updated: 2013-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
1998-03-31
2003-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
9-aminocamptothecin (25 mcg/m2/hr x 120hrs, days 1-5 and 8-12 of each 3 week cycle)
aminocamptothecin
Interventions
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aminocamptothecin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Hedy L. Kindler, MD
Role: STUDY_CHAIR
University of Chicago
Locations
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University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States
Countries
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Other Identifiers
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UCCRC-9025
Identifier Type: -
Identifier Source: secondary_id
NCI-T97-0013
Identifier Type: -
Identifier Source: secondary_id
9025
Identifier Type: -
Identifier Source: org_study_id