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

Phase 2

Terminated

• Conditions: Kidney Cancer
• Interventions: Drug: gemcitabine hydrochloride; Drug: irinotecan hydrochloride

• Registration Number: NCT00089102
• Lead Sponsor: Medical University of South Carolina

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.

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 Timeline

• Study Start: 2003-09
• Study First Submitted: 2004-08-04
• Study First Submitted QC: 2004-08-04
• Study First Posted: 2004-08-05
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2018-05-04
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-13
• Last Update Submitted: 2018-07-13
• Results First Posted: 2018-07-16
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine + Irinotecan	gemcitabine hydrochloride	-
Gemcitabine + Irinotecan	irinotecan hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Response Proportion	From registration until time of complete response or partial response

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center; 🇺🇸 Spartanburg, South Carolina, United States

Hollings Cancer Center at Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States