Status:
COMPLETED
S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Stromal Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
OBJECTIVES: * Determine the complete and partial response (confirmed and unconfirmed) in patients with unresectable or metastatic gastrointestinal stromal tumors treated with temozolomide. * Determin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00005597
Start Date
April 1 2000
End Date
October 1 2005
Last Update
January 3 2013
Active Locations (106)
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1
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
2
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
3
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States, 85012
4
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723