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Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
First Received: November 16, 2006   Last Updated: July 23, 2008   History of Changes
Sponsored by: Case Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00401128
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with irinotecan works in treating patients with metastatic kidney cancer.


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

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response [ Designated as safety issue: No ]
  • Safety and efficacy [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Difference in response to therapy in patients with clear vs nonclear cell renal cell carcinoma [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2004
Detailed Description:

OBJECTIVES:

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

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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 years
  • 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

PRIOR CONCURRENT THERAPY:

  • Recovered from prior hormonal therapy, radiotherapy, biologic therapy, or chemotherapy
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401128

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Ronald M. Bukowski, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000446096, CASE-CCF-6695
Study First Received: November 16, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00401128     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
clear cell renal cell carcinoma
recurrent renal cell cancer
papillary renal cell carcinoma
stage IV renal cell cancer

Study placed in the following topic categories:
Antimetabolites
Urinary Tract Neoplasm
Anti-Infective Agents
Immunologic Factors
Irinotecan
Urogenital Neoplasms
Urologic Neoplasms
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Kidney Diseases
Gemcitabine
Kidney Cancer
Chromophil Renal Cell Carcinoma
Antiviral Agents
Immunosuppressive Agents
Recurrence
Camptothecin
Carcinoma
Papillary Renal Cell Carcinoma
Radiation-Sensitizing Agents
Clear Cell Renal Cell Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Irinotecan
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Kidney Diseases
Gemcitabine
Neoplasms by Histologic Type
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Camptothecin
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Carcinoma, Renal Cell
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009