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Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma


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

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Trial Information

Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma


OBJECTIVES:

Primary

- Determine response in patients with locally advanced unresectable or metastatic renal
cell carcinoma treated with gemcitabine and irinotecan.

Secondary

- Determine the duration of response in patients treated with this regimen.

- Determine the tolerance to and toxicity of this regimen in these patients.

- Determine median and progression-free survival in patients treated with this regimen.

OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes
on days 1 and 8. Treatment repeats every 21 days for 6-8 courses in the absence of disease
progression or unacceptable toxicity. Patients receive 2 additional courses beyond best
response.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study within 30
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell carcinoma

- Locally advanced unresectable or metastatic disease

- Unidimensionally measurable disease by physical exam or imaging study

- The following are not considered measurable disease:

- Bone only disease

- Pleural or peritoneal effusions

- CNS lesions

- Irradiated lesions unless disease progression was documented after
radiotherapy

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- ALT and AST < 3 times upper limit of normal

- Bilirubin ≤ 2.0 mg/dL

Renal

- Creatinine ≤ 2.0 mg/dL

Gastrointestinal

- No active inflammatory bowel disease

- No significant bowel obstruction

- No chronic diarrhea

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
participation

- No mental incapacitation or psychiatric illness that would preclude giving informed
consent

- No other active malignancy except nonmelanoma skin cancer

- No other severe disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 4 weeks since prior immunotherapy

- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormones except steroids for adrenal failure, hormones for
non-disease-related conditions (e.g., insulin for diabetes), or intermittent
dexamethasone as an antiemetic

Radiotherapy

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No concurrent palliative radiotherapy

Surgery

- Not specified

Other

- No concurrent participation in another clinical trial

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Safety Issue:

No

Principal Investigator

Uzair B. Chaudhary, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Federal Government

Study ID:

CDR0000378044

NCT ID:

NCT00089102

Start Date:

September 2003

Completion Date:

July 2009

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303