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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 CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
CCOP - MeritCare HospitalFargo, North Dakota  58122
St. Rita's Medical CenterLima, Ohio  45801
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
Swedish Covenant HospitalChicago, Illinois  60625
Mercy Hospital and Medical CenterChicago, Illinois  60616
Hematology and Oncology AssociatesChicago, Illinois  60611
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
Northwest Medical Specialist, PCNiles, Illinois  60714
Midwest Cancer Research Group, IncorporatedSkokie, Illinois  60077
Hematology/Oncology of the North Shore at Gross Point Medical CenterSkokie, Illinois  60076
McFarland Clinic, P. C.Ames, Iowa  50010
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
MeritCare Medical GroupFargo, North Dakota  58122