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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
N/A
Not Enrolling
Both
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


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 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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with clinical response

Safety Issue:

No

Principal Investigator

David F. McDermott, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000349502

NCT ID:

NCT00077129

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

Name

Location

CCOP - Carle Cancer Center Urbana, Illinois  61801
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
CCOP - MeritCare Hospital Fargo, North Dakota  58122
St. Rita's Medical Center Lima, Ohio  45801
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
St. Luke's Hospital Cancer Center Bethlehem, Pennsylvania  18015
Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx, New York  10466
Baptist Cancer Institute - Jacksonville Jacksonville, Florida  32207
Swedish-American Regional Cancer Center Rockford, Illinois  61104-2315
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Hematology Oncology Associates - Skokie Skokie, Illinois  60076
Swedish Covenant Hospital Chicago, Illinois  60625
Mercy Hospital and Medical Center Chicago, Illinois  60616
Hematology and Oncology Associates Chicago, Illinois  60611
Midwest Center for Hematology/Oncology Joliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville, Illinois  60048
Northwest Medical Specialist, PC Niles, Illinois  60714
Midwest Cancer Research Group, Incorporated Skokie, Illinois  60077
Hematology/Oncology of the North Shore at Gross Point Medical Center Skokie, Illinois  60076
McFarland Clinic, P. C. Ames, Iowa  50010
St. Luke's Hospital Cedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids, Iowa  52403
MeritCare Clinic - Bemidji Bemidji, Minnesota  56601
MeritCare Medical Group Fargo, North Dakota  58122