Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer

NCT00401128 | Completed Phase 2 FDA Drug

• 2 other identifiers: CASE-CCF-6695P30CA043703
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Cancer

Keywords

clear cell renal cell carcinoma; recurrent renal cell cancer; papillary renal cell carcinoma; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Overall response

• Safety and efficacy

Secondary Outcomes (1)

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

Interventions

gemcitabine hydrochloride DRUG

irinotecan hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Gemcitabine; Irinotecan

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids

Study Officials

• Ronald M. Bukowski, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: May 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

US (1)