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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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 27 (106 locations)

    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