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Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Kidney Cancer

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Trial Information

Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma


- Determine the response rate in patients with epithelial (clear or nonclear cell) renal
cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan

- Compare the response in patients with clear cell RCC vs nonclear cell RCC treated with
this regimen.

- Determine the toxicities of this regimen.

OUTLINE: This is an open-label study.

Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride
IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses
in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed epithelial renal cell carcinoma (RCC),
including either clear cell or nonclear cell RCC

- Strong clinical evidence or biopsy proof of metastases to a site or sites distant
from the primary tumor

- Measurable disease

- No untreated or progressive CNS metastases


- ECOG performance status 0-1

- Life expectancy > 3 months

- Absolute neutrophil count > 1,500/mm³

- Platelet count > 100,000/mm³

- Hemoglobin > 9.5 g/dL

- Creatinine ≤ 1.8 mg/dL

- Bilirubin < 1.5 mg/dL

- Calcium < 11.5 mg/dL

- ALT and AST < 3 times upper limit of normal

- No history of any of the following:

- Serious cardiac arrhythmia or cardiac arrhythmia requiring treatment

- Congestive heart failure

- Angina pectoris

- Other severe cardiovascular disease producing limitations of physical activity
(i.e., New York Heart Association class III-IV heart disease)

- No other prior malignancy except for the following:

- Basal cell or squamous cell carcinoma of the skin

- Carcinoma in situ of the uterine cervix

- Any malignancy treated with curative intent and in complete remission for > 3

- No active peptic ulcer disease, inflammatory bowel disease, or chronic diarrhea

- No local or systemic infections requiring IV antibiotics within the past 28 days

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


- Recovered from prior hormonal therapy, radiotherapy, biologic therapy, or

- No more than 3 prior therapeutic regimens for metastatic disease

- No prior organ allograft

- More than 28 days since prior major surgery requiring general anesthesia

- More than 28 days since prior radiotherapy to control pain from skeletal lesions

- More than 28 days since prior hormonal treatment

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response

Safety Issue:


Principal Investigator

Ronald M. Bukowski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

May 2004

Completion Date:

Related Keywords:

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



Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065