S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

• Status: Completed
• Trial end date: 2005-10-01
• 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 temozolomide in treating patients who have unresectable or metastatic gastrointestinal stromal tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed unresectable or metastatic gastrointestinal stromal tumor (GIST)

• Primary (gastrointestinal or intra-abdominal origin) tumor

• At least 1 measurable lesion by x-ray, CT, MRI, ultrasound, or physical examination

• If lesions within prior radiation port are used as target lesions for response assessment, those lesions must have demonstrated clear progression after completion of radiotherapy

• No uterine or retroperitoneal sarcomas or non-intra-abdominal leiomyosarcomas

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC (white blood count) at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No medical or psychological conditions that would preclude study participation

• No major infection requiring systemic antibiotics

• No uncontrolled bacterial, viral, or fungal infection

• No other prior malignancy within the past 5 years except:

• Adequately treated basal cell or squamous cell skin cancer

• Adequately treated stage I or II cancer in complete remission

• Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 30 days since prior biologic therapy

• Prior imatinib mesylate as adjuvant therapy or for metastatic disease allowed

Chemotherapy:

• No prior chemotherapy for GIST

• At least 30 days since other prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy for GIST

• No concurrent radiotherapy for GIST

• Concurrent palliative radiotherapy for painful metastases (encompassing a total portal of no greater than 5 x 5 cm) allowed

Surgery:

• See Disease Characteristics

• At least 4 weeks since prior major surgery and recovered

Other:

• At least 30 days since prior investigational drugs