Clinical trial NCT00077129: Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Cancer
Official title: Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-02-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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.

Eligibility 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

Primary outcomes:
measure: Proportion of patients with clinical response
Secondary outcomes:
measure: Toxicity
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baptist Cancer Institute - Jacksonville
state: Florida
city: Aurora
country: United States
facility: Rush-Copley Cancer Care Center
state: Illinois
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Hematology and Oncology Associates
state: Illinois
city: Chicago
country: United States
facility: Veterans Affairs Medical Center - Lakeside Chicago
state: Illinois
city: Chicago
country: United States
facility: Mercy Hospital and Medical Center
state: Illinois
city: Chicago
country: United States
facility: Swedish Covenant Hospital
state: Illinois
city: Joliet
country: United States
facility: Midwest Center for Hematology/Oncology
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Limited - West
state: Illinois
city: Libertyville
country: United States
facility: North Shore Oncology and Hematology Associates, Limited - Libertyville
state: Illinois
city: Niles
country: United States
facility: Northwest Medical Specialist, PC
state: Illinois
city: Rockford
country: United States
facility: Swedish-American Regional Cancer Center
state: Illinois
city: Skokie
country: United States
facility: Hematology Oncology Associates - Skokie
state: Illinois
city: Skokie
country: United States
facility: Hematology/Oncology of the North Shore at Gross Point Medical Center
state: Illinois
city: Skokie
country: United States
facility: Midwest Cancer Research Group, Incorporated
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center at Carle Foundation Hospital
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Michigan City
country: United States
facility: Saint Anthony Memorial Health Centers
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic, P. C.
state: Iowa
city: Cedar Rapids
country: United States
facility: St. Luke's Hospital
state: Iowa
city: Cedar Rapids
country: United States
facility: Cedar Rapids Oncology Associates
state: Iowa
city: Cedar Rapids
country: United States
facility: Mercy Regional Cancer Center at Mercy Medical Center
state: Iowa
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Bemidji
country: United States
facility: MeritCare Clinic - Bemidji
state: Minnesota
city: Bronx
country: United States
facility: Our Lady of Mercy Medical Center Comprehensive Cancer Center
state: New York
city: Fargo
country: United States
facility: CCOP - MeritCare Hospital
state: North Dakota
city: Fargo
country: United States
facility: MeritCare Medical Group
state: North Dakota
city: Lima
country: United States
facility: St. Rita's Medical Center
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's Hospital Cancer Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Medical X-Ray Center, PC
state: South Dakota
city: Sioux Falls
country: United States
facility: Sioux Valley Hospital and University of South Dakota Medical Center
state: South Dakota
city: La Crosse
country: United States
facility: Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
state: Wisconsin
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: David F. McDermott, MD
role: STUDY_CHAIR
affiliation: Beth Israel Deaconess Medical Center
name: Michael B. Atkins, MD
role: STUDY_CHAIR
References: