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A Phase II Trial of Gemzar (Gemcitabine) and Gleevec (Imatinib Mesylate) in Patients With Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

A Phase II Trial of Gemzar (Gemcitabine) and Gleevec (Imatinib Mesylate) in Patients With Metastatic Renal Cell Carcinoma


OBJECTIVES:

Primary

- Compare stable disease and objective response in patients with metastatic or
unresectable renal cell carcinoma treated with gemcitabine hydrochloride with or
without imatinib mesylate.

Secondary

- Evaluate the median survival, progression-free survival, and response rate in patients
treated with gemcitabine hydrochloride and imatinib mesylate.

- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.

- Determine the expression of c-KIT and platelet-derived growth factor receptor-alpha
protein expression in both tumor cells and associated endothelial cells using
immunohistochemistry staining of paraffin-embedded tissue.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by histology
(clear cell vs nonclear cell) and prior therapy (immunotherapy/chemotherapy vs targeted
agents).

Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate on
days 1-5 and 8-12. Treatment repeats every 21 days for up to 2 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving partial or complete
response after 2 courses of treatment continue treatment with gemcitabine hydrochloride and
imatinib mesylate in the absence of disease progression or unacceptable toxicity. Patients
with stable disease after 2 courses of treatment are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive gemcitabine hydrochloride IV on days 3 and 10.

- Arm II: Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral
imatinib mesylate on days 1-5 and 8-12.

In both arms, treatment repeats every 21 days for at least 3 courses in the absence of
disease progression or unacceptable toxicity.

Available archived tumor tissue samples are obtained for immunohistochemical analysis to
quantify the expression of c-KIT and platelet-derived growth factor receptor-alpha protein
expression.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Stable disease

Safety Issue:

No

Principal Investigator

Mark Stein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000539400

NCT ID:

NCT00323791

Start Date:

April 2006

Completion Date:

August 2007

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • clear cell renal cell carcinoma
  • papillary renal cell carcinoma
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903