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

Kidney Cancer Clinical Trial

Official title:

Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00089102
• Other study ID #: CDR0000378044
• Secondary ID: MUSC-100730MUSC-
• Status: Terminated
• Phase: Phase 2
• Start date: September 2003
• Est. completion date: July 2009

Study information

• Verified date: July 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

• Locally advanced unresectable or metastatic disease

• Unidimensionally measurable disease by physical exam or imaging study

• The following are not considered measurable disease:

• Bone only disease

• Pleural or peritoneal effusions

• CNS lesions

• Irradiated lesions unless disease progression was documented after radiotherapy

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count = 1,500/mm^3

• Platelet count = 100,000/mm^3

Hepatic

• ALT and AST < 3 times upper limit of normal

• Bilirubin = 2.0 mg/dL

Renal

• Creatinine = 2.0 mg/dL

Gastrointestinal

• No active inflammatory bowel disease

• No significant bowel obstruction

• No chronic diarrhea

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study participation

• No mental incapacitation or psychiatric illness that would preclude giving informed consent

• No other active malignancy except nonmelanoma skin cancer

• No other severe disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 4 weeks since prior immunotherapy

• No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

• No prior chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• No concurrent palliative radiotherapy

Surgery

• Not specified

Other

• No concurrent participation in another clinical trial

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride
1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle
• irinotecan hydrochloride
100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle

Locations

Country	Name	City	State
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Proportion		From registration until time of complete response or partial response
Secondary	Duration of Response		From registration until disease progression among patients who had at least a partial response
Secondary	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
Secondary	Progression-free Survival		Time between registration and disease progression or death, whichever comes first.