Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

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

Lead Sponsor:

Medical University of South Carolina

Conditions:

Kidney Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

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 m...

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 durati...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2009

    Estimated Enrollment :

    9 Patients enrolled

    Trial Details

    Trial ID

    NCT00089102

    Start Date

    September 1 2003

    End Date

    July 1 2009

    Last Update

    July 16 2018

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, United States, 29425

    2

    Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, United States, 29303