Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer

Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer
• Intervention / Treatment: Drug: irinotecan hydrochloride; Drug: gemcitabine hydrochloride

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and efficacy
Overall response

Secondary Outcome Measures

Outcome Measure
Difference in response to therapy in patients with clear vs nonclear cell renal cell carcinoma

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: November 16, 2006
• First Submitted That Met QC Criteria: November 16, 2006
• First Posted (Estimate): November 17, 2006

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: stage IV renal cell cancer; recurrent renal cell cancer; clear cell renal cell carcinoma; papillary renal cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Gemcitabine; Irinotecan
• Other Study ID Numbers: CASE-CCF-6695; P30CA043703 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No