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Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer

Primary Purpose

Kidney Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

gemcitabine hydrochloride

irinotecan hydrochloride

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring clear cell renal cell carcinoma, recurrent renal cell cancer, papillary renal cell carcinoma, stage IV renal cell cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Case Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Overall response

Safety and efficacy

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00401128

First Posted

November 16, 2006

Last Updated

April 18, 2017

Sponsor

The Cleveland Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00401128

Brief Title

Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Type

Drug

Intervention Name(s)

irinotecan hydrochloride

Primary Outcome Measure Information:

Title

Overall response

Title

Safety and efficacy

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald M. Bukowski, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-5065

Country

United States

12. IPD Sharing Statement

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Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer

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