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Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer

Phase 2
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer



- 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

Inclusion Criteria


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with clinical response

Safety Issue:


Principal Investigator

David F. McDermott, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



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