Gemcitabine With or Without Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer

NCT00323791 | Terminated Phase 2 DMC

• 5 other identifiers: CDR0000539400P30CA072720CINJ-080507CINJ-5633CINJ-NJ3805
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells. PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see how well they work compared with gemcitabine alone in treating patients with metastatic or unresectable kidney cancer.

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer; clear cell renal cell carcinoma; papillary renal cell carcinoma; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Stable disease

• Objective response

Secondary Outcomes (4)

• Median survival

• Progression-free survival

• Response rate

• Expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression

Interventions

gemcitabine hydrochloride DRUG

imatinib mesylate DRUG

gene expression analysis GENETIC

protein expression analysis GENETIC

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed renal cell carcinoma * Metastatic disease OR unresectable primary tumor * No known curative therapy exists * Documented progressive renal cell carcinoma as defined by RECIST criteria within the past 6 months * Measurable disease with ≥ 1 unidimensionally measurable lesion * No known symptomatic brain metastasis or untreated brain metastases or carcinomatous meningitis * Treated brain metastasis allowed provided the following criteria are met: * Clinically stable * More than 7 days since prior steroids PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception during and for 3 months after completion of study treatment * Must be able to swallow oral medication * No coexisting medical condition that would preclude study compliance * No history of allergic reaction to compounds of similar chemical or biological composition to gemcitabine hydrochloride and/or imatinib mesylate * No uncontrolled illness that would preclude study participation * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia requiring therapy * No myocardial infarction within the past 6 months * No active infection * No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer * No New York Heart Association class III-IV congestive heart failure * No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis) * No known HIV positivity * No significant history of noncompliance to medical regimens PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy * No more than 3 prior treatment regimens, including any of the following: * No more than 1 prior cytotoxic therapy * Immunotherapy regimens comprising interferon and/or aldesleukin * Therapy with molecular targets * Any combination of the above treatments to a maximum of 3 total therapies * No prior gemcitabine hydrochloride for metastatic disease * No prior imatinib mesylate for metastatic disease * More than 2 weeks since prior major surgery * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) * At least 3 weeks since prior anti-vascular endothelial growth factor therapy * At least 3 weeks since prior radiotherapy * Must have evidence of ≥ 1 measurable target lesion outside the radiation fields OR radiologically confirmed disease progression within the radiation fields after completion of radiotherapy * At least 28 days since prior and no other concurrent investigational or commercial agents, unless disease is rapidly progressing * No concurrent therapeutic warfarin * Concurrent low molecular weight heparin or heparin allowed for therapeutic anticoagulation * Concurrent prophylactic warfarin therapy ≤ 1 mg daily to maintain catheter patency allowed * No concurrent filgrastim (G-CSF) for prevention of neutropenia * No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiation therapy, or cancer surgery * No concurrent routine use (i.e., daily or every other day) of systemic corticosteroid therapy (in supraphysiologic doses) * No concurrent medication that would preclude study compliance

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Gemcitabine; Imatinib Mesylate; Gene Expression Profiling; Immunohistochemistry

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Genetic Techniques; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques

Study Officials

• Mark Stein, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 10, 2006
• Study Start: April 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 11, 2009

Record last verified: 2009-12

Locations

US (1)