Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor

Stopped early · Phase 3

Conditions studied: Gastrointestinal Stromal Tumor

In brief

This randomized phase III trial studies imatinib mesylate and bevacizumab to see how well they work compared to imatinib mesylate alone in treating patients with gastrointestinal stromal tumor that has spread to other parts of the body or cannot be removed by surgery. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether imatinib mesylate and bevacizumab are more effective than imatinib mesylate alone in treating gastrointestinal stromal tumor.

Key facts

Study ID

NCT00324987

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2008-04-01

Expected to finish

2015-07-01

Last updated by the study team

2017-09-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• REGISTRATION # 1
• Patient must have a biopsy proven diagnosis of gastrointestinal stromal tumor (GIST) that is distantly metastatic or unresectable; patients must be determined to be unresectable for cure
• Patient may have measurable and/or non-measurable disease; computed tomography (CT) or magnetic resonance imaging (MRI) used for measurable disease must have been completed within 28 days prior to registration; CT or MRI used for non-measurable disease must have been completed within 42 days prior to registration; PET scans are not sufficient for disease assessment; all disease must be assessed and documented on the Baseline Tumor Assessment Form
• CT/MRI scans must be performed and submitted for central review; archived tissue must be submitted as outlined
• Institutions must seek additional patient consent for PET scans as outlined; if patient consents to the submission of PET scans, the patient must also be registered to Registration #2
• Patient must not have known brain metastasis
• Patient must have a Zubrod performance status of 0 - 3
• Patient must have resolution of transient toxicities from any prior chemotherapy, radiation therapy or surgery to =< grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
• Patient may have previously received traditional chemotherapeutic agents in any setting, provided at least 28 days have elapsed since completing chemotherapy and they have recovered to =< grade 1 from all drug-induced toxicities
• Patient must not have received prior treatment with bevacizumab or other agents targeting VEGF, VEGFR, or PDGFR for advanced disease; those agents may have been used in the adjuvant setting if the patient did not recur for at least 12 months following the completion of treatment; patients may be receiving imatinib for advanced disease prior to registration provided they meet ALL of the following criteria:
• Patient must not have received more than 30 days of imatinib treatment prior to registration
• Patients have not been restaged; (baseline disease assessments prior to initiation of imatinib must fulfill requirements)
• Patients must have no clinical signs of progression
• Prior radiotherapy is allowed, provided at least 28 days have elapsed since the last treatment and there is evidence of progressive disease within the radiation field or disease outside the radiation field
• Patient must not have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration, or anticipation of need for major surgical procedure during the course of the study; no fine needle aspirations or core biopsies are allowed within 7 days prior to registration; no procedure to place a port-a-cath is allowed within 7 days prior to registration
• Patient must have a total bilirubin =< 2.0 x institutional upper limit of normal (IULN), obtained within 28 days prior to registration
• Patients without liver involvement must have serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =< 2.5 x IULN, obtained within 28 days prior to registration; patients with liver involvement must have SGOT or SGPT =< 5 x IULN
• Patient must have adequate renal function as defined by a serum creatinine =< 1.5 x IULN obtained within 28 days prior to registration
• Patient must have urine protein/creatinine ratio (UPC) < 1; this result must be obtained within 28 days prior to registration
• Patient must have an absolute neutrophil count (ANC) >= 1,000/mcl obtained within 28 days prior to registration
• Patient must have a platelet count >= 100,000/mcl obtained within 28 days prior to registration
• Patient must have hemoglobin >= 9 gm/dl (this may be achieved by transfusion if needed) obtained within 28 days prior to registration
• Patient must have an international normalized ratio (INR) =< 1.5, obtained within 28 days prior to registration
• Patient must have a partial thromboplastin time (PTT) =< IULN, obtained within 28 days prior to registration
• Patient must not be taking therapeutic doses of Coumadin (warfarin) as anticoagulation at the time of registration; patients requiring therapeutic anticoagulation may use low-molecular weight heparin (e.g., Lovenox) or other agents, and mini-dose Coumadin (1 mg PO QD) as prophylaxis is allowed

Where it is running

• Mills - Peninsula Hospitals — Burlingame, California, United States
• Marin General Hospital — Greenbrae, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Sutter Cancer Research Consortium — Novato, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• Sutter Solano Medical Center/Cancer Center — Vallejo, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• John B Amos Cancer Center — Columbus, Georgia, United States
• Memorial University Medical Center — Savannah, Georgia, United States
• South Georgia Medical Center — Valdosta, Georgia, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• Presence Resurrection Medical Center — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Joliet Oncology-Hematology Associates Limited — Joliet, Illinois, United States
• Adventist La Grange Memorial Hospital — La Grange, Illinois, United States
• Edward Hospital/Cancer Center — Naperville, Illinois, United States
• Memorial Medical Center — Springfield, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Carle Clinic-Urbana Main — Urbana, Illinois, United States
• Franciscan St. Francis Health-Beech Grove — Beech Grove, Indiana, United States
• Franciscan Saint Anthony Health-Michigan City — Michigan City, Indiana, United States
• Reid Hospital and Health Care Services — Richmond, Indiana, United States
• McFarland Clinic PC-William R Bliss Cancer Center — Ames, Iowa, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States

Full record on ClinicalTrials.gov

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