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

This study has been completed.
Information provided by (Responsible Party):
Medical University of South Carolina Identifier:
First received: August 4, 2004
Last updated: April 26, 2012
Last verified: April 2012

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.

Condition Intervention Phase
Kidney Cancer
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Overall response rate [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: September 2003
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:



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


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • ALT and AST < 3 times upper limit of normal
  • Bilirubin ≤ 2.0 mg/dL


  • Creatinine ≤ 2.0 mg/dL


  • No active inflammatory bowel disease
  • No significant bowel obstruction
  • No chronic diarrhea


  • 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


Biologic therapy

  • At least 4 weeks since prior immunotherapy
  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)


  • 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


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent palliative radiotherapy


  • Not specified


  • No concurrent participation in another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00089102

United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Medical University of South Carolina
Principal Investigator: Uzair B. Chaudhary, MD Medical University of South Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: Medical University of South Carolina Identifier: NCT00089102     History of Changes
Other Study ID Numbers: CDR0000378044, MUSC-100730, MUSC-HR-10981, PHARMACIA-B9E-US-X388, LILLY-MUSC-100730
Study First Received: August 4, 2004
Last Updated: April 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
recurrent renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on November 24, 2015