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Oblimersen and Imatinib Mesylate in Treating Patients With Advanced Gastrointestinal Stromal Tumors That Cannot Be Removed By Surgery
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00091078
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Oblimersen may help imatinib mesylate kill more tumor cells by making tumor cells more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with oblimersen works in treating patients with advanced gastrointestinal stromal tumor that cannot be removed by surgery.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: imatinib mesylate
Drug: oblimersen
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Imatinib Imatinib mesylate Oblimersen sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase IIA Study to Determine the Safety and Efficacy of G3139 and Imatinib Mesylate in Patients With Refractory or Relapsed Gastrointestinal Stromal Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as determined by computer tomography measurements every 2 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival as measured by computed tomography every 2 months [ Designated as safety issue: No ]
  • Progression-free survival as measured by follow up physical exam [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: December 2005
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of oblimersen and imatinib mesylate in patients with advanced unresectable gastrointestinal stromal tumors that progressed after prior imatinib mesylate.
  • Determine the safety of this regimen in these patients.
  • Correlate expression of bcl-2 with survival, time to progression, and response rate in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to extent of disease progression (limited vs generalized).

Patients receive oblimersen IV continuously on days 1-14. Patients also receive oral imatinib mesylate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 96 patients (48 per stratum) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed gastrointestinal stromal tumor

    • Advanced disease, defined as unresectable mestastatic or primary disease
  • Kit-expressing tumor
  • Limited* or generalized** disease progression after adequate therapy with imatinib mesylate (≥ 400 mg/day for at least 6 weeks), as defined by both of the following:

    • Increase in unidimensional tumor size of ≥ 10% AND did not meet criteria for partial response by CT scan density
    • Any new lesions, including new tumor nodules in a previous cystic tumor NOTE: *Some, but not all, tumor foci progressing AND not amenable to local therapy

NOTE: **Widespread progression of all tumor foci

  • Measurable disease by CT scan

    • If a targeted lesion has been previously embolized or irradiated, there must be objective evidence of disease progression

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • PT and PTT ≤ 1.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • No uncontrolled chronic liver disease

Renal

  • Creatinine ≤ 1.5 times ULN
  • No uncontrolled chronic renal disease

Cardiovascular

  • No New York Heart Association class III or IV cardiac disease
  • No congestive heart failure
  • No acute myocardial infarction within the past 2 months

Other

  • Intellectually, emotionally, and physically able to maintain an ambulatory infusion pump
  • No uncontrolled diabetes
  • No uncontrolled seizure disorder
  • No active uncontrolled infection
  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other concurrent significant medical disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior biologic therapy

Chemotherapy

  • At least 4 weeks since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • No prior organ allografts

Other

  • Recovered from all prior therapy such that severity is ≤ grade 1 for nonhematological toxicities except nausea and vomiting controlled with standard anti-emetic regimens, alopecia, fatigue, and peripheral edema
  • At least 4 weeks since prior embolization
  • At least 4 weeks since prior imatinib mesylate
  • At least 4 weeks since other prior therapy
  • No concurrent warfarin

    • Low-dose warfarin or low molecular weight heparin allowed for prophylaxis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091078

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021-6007
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Jonathan C. Trent, MD, PhD M.D. Anderson Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000383199, MDA-2003-0761, NCI-6122
Study First Received: September 7, 2004
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00091078  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
gastrointestinal stromal tumor

Study placed in the following topic categories:
Imatinib
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009