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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00089102
Recruitment Status : Terminated (Low accrual)
First Posted : August 5, 2004
Results First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Kidney Cancer Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma
Study Start Date : September 2003
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Gemcitabine + Irinotecan Drug: gemcitabine hydrochloride
1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle

Drug: irinotecan hydrochloride
100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle


Outcome Measures
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Primary Outcome Measures :
  1. Response Proportion [ Time Frame: From registration until time of complete response or partial response ]

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: From registration until disease progression among patients who had at least a partial response ]
  2. Number of Participants Who Experienced SAEs on Study [ Time Frame: From the day of first dose until the end of study, for an average of 6 months ]
  3. Progression-free Survival [ Time Frame: Time between registration and disease progression or death, whichever comes first. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089102


Locations
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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
Investigators
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Principal Investigator: Uzair B. Chaudhary, MD Medical University of South Carolina
Study Chair: Gustavo Leone Medical University of South Carolina, Hollings Cancer Center
More Information
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00089102    
Other Study ID Numbers: CDR0000378044
MUSC-100730
MUSC-HR-10981
PHARMACIA-B9E-US-X388
LILLY-MUSC-100730
First Posted: August 5, 2004    Key Record Dates
Results First Posted: July 16, 2018
Last Update Posted: July 16, 2018
Last Verified: July 2018
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:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
 Irinotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors