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Imatinib Mesylate, Gemcitabine, and Capecitabine in Treating Patients With Advanced Solid Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: University of Nebraska
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00483366
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with gemcitabine and capecitabine may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine and capecitabine when given together with imatinib mesylate in treating patients with advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: capecitabine
Drug: gemcitabine hydrochloride
Drug: imatinib mesylate
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Imatinib Imatinib mesylate Capecitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Imatinib, Gemcitabine and Capecitabine in Patients With Solid Tumors

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

Primary Outcome Measures:
  • Maximum tolerated dose of gemcitabine hydrochloride and capecitabine when combined with imatinib mesylate [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: August 2006
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of gemcitabine hydrochloride and capecitabine when combined with imatinib mesylate in patients with advanced solid tumors.
  • Determine the toxicity of this regimen in these patients.

Secondary

  • Explore the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of gemcitabine and capecitabine.

Patients receive oral imatinib mesylate once daily on days 1-5 and 8-12, gemcitabine hydrochloride IV on days 3 and 10, and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of progressive disease or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor, meeting 1 of the following criteria:

    • Failed standard therapy and subsequent line therapy
    • Disease for which no standard therapy exists
  • Any number of prior therapies are allowed provided standard treatment options have either been exhausted or are unable to be administered, in the opinion of the treating physician
  • Measurable or nonmeasurable disease

    • Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by CT scan or ≥ 10 mm by spiral CT scan
    • Nonmeasurable disease is defined as all other lesions, including small lesions (< 20 mm by conventional techniques or < 10 mm by spiral CT scan) and truly nonmeasurable lesions, including the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural or pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
  • Brain metastases allowed provided both of the following are true:

    • Patient has undergone resection and/or radiotherapy and does not require steroids
    • No evidence of disease progression by CT scan or MRI at least 4 weeks after completion of steroids, surgery, and/or radiotherapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.5 g/dL (epoetin alfa supplementation allowed)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) (except if due to Gilbert's syndrome)
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine < 1.5 times ULN
  • 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
  • Must be able to tolerate oral intake for the administration of imatinib mesylate and capecitabine
  • No active serious infections
  • No known allergy or hypersensitivity to study drugs or their formulation
  • No comorbidity or condition which, in the opinion of the investigator, would preclude study participation
  • No other primary malignancy within the past 5 years except basal cell skin cancer, cervical carcinoma in situ, or another primary malignancy that is not currently clinically significant or requires active intervention
  • No other malignant disease
  • No New York Heart Association class III-IV cardiac disease
  • No congestive heart failure
  • No myocardial infarction within the past 6 months
  • No known chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
  • No known HIV infection

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior treatment with gemcitabine hydrochloride, capecitabine, or imatinib mesylate allowed provided all three drugs were not used in combination simultaneously
  • Prior radiotherapy allowed provided the lesion treated is not used to assess response and has not demonstrated progression after treatment
  • At least 2 weeks since prior radiotherapy
  • More than 2 weeks since prior major surgery
  • At least 4 weeks since prior systemic therapy (6 weeks for nitrosoureas) and recovered
  • More than 4 weeks since prior packed red blood cell transfusions
  • No prior radiotherapy to ≥ 25% of the bone marrow
  • No concurrent anticoagulation therapy with warfarin

    • Therapeutic anticoagulation with low-molecular weight heparin or heparin allowed
    • Mini-dose warfarin (e.g., 1 mg/day) for prophylaxis of central venous catheter thrombosis allowed at the discretion of the treating physician
  • No other concurrent anticancer agents, including chemotherapy and biologic agents
  • No other concurrent investigational drugs
  • No concurrent routine systemic corticosteroid therapy (corticosteroid therapy may only be administered after consultation with the principal investigator)
  • Concurrent bisphosphonate therapy allowed for skeletal metastases provided therapy is started before study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483366

Locations
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Mary Mailliard, RN, BSN, OCN     402-559-5582     mjmailli@unmc.edu    
Sponsors and Collaborators
University of Nebraska
Investigators
Study Chair: Ralph Hauke, MD University of Nebraska
Investigator: Elizabeth C. Reed, MD University of Nebraska
  More Information

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

Study ID Numbers: CDR0000547168, UNMC-16306
Study First Received: June 6, 2007
Last Updated: December 31, 2008
ClinicalTrials.gov Identifier: NCT00483366  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Imatinib
Capecitabine
Gemcitabine

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009