Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer

Medical University of South Carolina (MUSC)

Status and phase

Terminated

Phase 2

Conditions

Kidney Cancer

Treatments

Drug: irinotecan hydrochloride

Drug: gemcitabine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00089102

MUSC-HR-10981

PHARMACIA-B9E-US-X388

LILLY-MUSC-100730

MUSC-100730

CDR0000378044

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced unresectable or metastatic kidney cancer.

Full description

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.

Enrollment

9 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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