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

NCT00077129 | Completed Phase 2

• 2 other identifiers: CDR0000349502E2803
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 35

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.

Conditions

Kidney Cancer

Keywords

stage III renal cell cancer; stage IV renal cell cancer; recurrent renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with clinical response

Secondary Outcomes (1)

• Toxicity

Interventions

carboplatin DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (35)

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Hematology and Oncology Associates

Chicago, Illinois, 60611, United States

Location

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, 60611, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616, United States

Location

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

Midwest Center for Hematology/Oncology

Joliet, Illinois, 60432, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

North Shore Oncology and Hematology Associates, Limited - Libertyville

Libertyville, Illinois, 60048, United States

Location

Northwest Medical Specialist, PC

Niles, Illinois, 60714, United States

Location

Swedish-American Regional Cancer Center

Rockford, Illinois, 61104-2315, United States

Location

Hematology Oncology Associates - Skokie

Skokie, Illinois, 60076, United States

Location

Hematology/Oncology of the North Shore at Gross Point Medical Center

Skokie, Illinois, 60076, United States

Location

Midwest Cancer Research Group, Incorporated

Skokie, Illinois, 60077, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

McFarland Clinic, P. C.

Ames, Iowa, 50010, United States

Location

St. Luke's Hospital

Cedar Rapids, Iowa, 52402, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

MeritCare Clinic - Bemidji

Bemidji, Minnesota, 56601, United States

Location

Our Lady of Mercy Medical Center Comprehensive Cancer Center

The Bronx, New York, 10466, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

MeritCare Medical Group

Fargo, North Dakota, 58122, United States

Location

St. Rita's Medical Center

Lima, Ohio, 45801, United States

Location

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• David F. McDermott, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

• Michael B. Atkins, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 11, 2004
• Study Start: June 1, 2006
• Primary Completion: August 1, 2006
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (35)