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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077129
Recruitment Status : Completed
First Posted : February 11, 2004
Last Update Posted : January 28, 2010
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

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 tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with locally advanced or metastatic collecting duct renal cell cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: carboplatin Drug: paclitaxel Phase 2

Detailed Description:



  • Determine the response rate in patients with locally advanced or metastatic collecting duct renal cell cancer treated with paclitaxel and carboplatin.


  • Determine the tolerability of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 14-22 patients will be accrued for this study within 4.5 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer
Study Start Date : September 2004
Actual Primary Completion Date : August 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Proportion of patients with clinical response

Secondary Outcome Measures :
  1. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • WBC ≥ 3,000/mm^3
  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN


  • Creatinine ≤ 2 times ULN


  • 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


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


  • Not specified

Endocrine therapy

  • Concurrent corticosteroids allowed


  • 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


  • See Disease Characteristics
  • No concurrent major surgery


  • No other concurrent anticancer drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077129

  Show 35 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: David F. McDermott, MD Beth Israel Deaconess Medical Center
Study Chair: Michael B. Atkins, MD Beth Israel Deaconess Medical Center

Responsible Party: Group Chair, Eastern Cooperative Oncology Group Identifier: NCT00077129     History of Changes
Other Study ID Numbers: CDR0000349502
First Posted: February 11, 2004    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010

Keywords provided by Eastern Cooperative Oncology Group:
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action