Overview
Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
Status:
Completed
Completed
Trial end date:
2003-08-01
2003-08-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of ChicagoCollaborator:
National Cancer Institute (NCI)Treatments:
9-aminocamptothecin
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed, locally advanced, metastatic orrecurrent 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
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