Overview

Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas

Status:
Completed
Trial end date:
2004-04-01
Target enrollment:
0
Participant gender:
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 nitrocamptothecin in treating patients who have locally advanced or metastatic soft tissue sarcomas.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astex Pharmaceuticals
Astex Pharmaceuticals, Inc.
Treatments:
Rubitecan
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic inoperable
soft tissue sarcoma Measurable or evaluable disease that has not been irradiated Must have
received, refused, or be not eligible for doxorubicin/ifosfamide treatment Previously
untreated gastrointestinal leiomyosarcoma allowed

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-2 Life expectancy:
At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no
greater than 3 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New
York Heart Association class III or IV heart disease No active coronary disease requiring
therapy Pulmonary: No severe pulmonary insufficiency Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception during and for 3
months after study No other prior malignancy in past 3 years except nonmelanoma skin cancer
or carcinoma in situ of the cervix No concurrent active infections No psychosis or mental
disability that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior biological therapy
and recovered No concurrent immunotherapy Chemotherapy: See Disease Characteristics At
least 3 weeks since prior chemotherapy and recovered No other concurrent chemotherapy
Endocrine therapy: At least 7 days since prior hormonal therapy and recovered Radiotherapy:
See Disease Characteristics Surgery: Not specified