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Status:

COMPLETED

Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Cancer

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Kidney Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more...

Detailed Description

OBJECTIVES: Primary * Determine the response rate in patients with locally advanced or metastatic collecting duct renal cell cancer treated with paclitaxel and carboplatin. Secondary * Determine t...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed collecting duct renal cell carcinoma
  • Advanced locally recurrent or metastatic disease
  • Not amenable to resection
  • Measurable disease
  • No active CNS metastases
  • Patients with CNS metastases previously treated with surgical resection and/or radiotherapy are eligible provided there is no evidence of disease progression by head CT scan or MRI at 3 months after the completion of definitive therapy
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • WBC ≥ 3,000/mm\^3
  • Absolute granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Renal
  • Creatinine ≤ 2 times ULN
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No peripheral neuropathy greater than grade 1
  • No other prior malignancy except for curatively treated cancer from which the patient has been disease-free for the length of time considered appropriate for cure of the specific cancer
  • No known hypersensitivity to Cremophor EL
  • No active serious infection
  • No other serious underlying medical condition that would preclude study therapy
  • No dementia or significantly altered mental status that would preclude giving informed consent
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No more than 2 prior biologic response modifier (BRM) regimens
  • Regimens may have included interleukin-2 and/or interferon alfa
  • At least 4 weeks since prior BRM therapy
  • Chemotherapy
  • Not specified
  • Endocrine therapy
  • Concurrent corticosteroids allowed
  • Radiotherapy
  • See Disease Characteristics
  • Prior radiotherapy allowed provided there is measurable disease that has not been irradiated OR there is clear evidence of tumor progression in an irradiated site
  • At least 4 weeks since prior radiotherapy
  • No concurrent external beam radiotherapy
  • Surgery
  • See Disease Characteristics
  • No concurrent major surgery
  • Other
  • No other concurrent anticancer drugs

Exclusion

    Key Trial Info

    Start Date :

    June 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    22 Patients enrolled

    Trial Details

    Trial ID

    NCT00077129

    Start Date

    June 1 2006

    Last Update

    June 18 2023

    Active Locations (35)

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

    Page 1 of 9 (35 locations)

    1

    Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, United States, 32207

    2

    Rush-Copley Cancer Care Center

    Aurora, Illinois, United States, 60507

    3

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, United States, 60611-3013

    4

    Hematology and Oncology Associates

    Chicago, Illinois, United States, 60611