Clinical trial NCT00003206: Carboplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer
Official title: A Phase II Trial of Carboplatin Plus Paclitaxel in the Treatment of Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: stage IV nasopharyngeal cancer
recurrent nasopharyngeal cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-16
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 use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating patients with locally recurrent or metastatic nasopharyngeal cancer.

Detailed description: OBJECTIVES: I. Estimate the response and toxicity of carboplatin in combination with paclitaxel in patients with locally recurrent or metastatic nasopharyngeal carcinoma.

OUTLINE: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. This cycle is repeated every 3 weeks. Patients may receive 6-8 cycles of therapy in the absence of toxicity and disease progression. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and yearly thereafter.

PROJECTED ACCRUAL: 30 eligible patients will be accrued in approximately 18 months.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed locally recurrent or metastatic nasopharyngeal carcinoma that is not curable with resection or radiation therapy Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 3.0 mg/dL Other: No active infections Serum calcium within institutional normal range No history of hypercalcemia Prior malignancy other than nasopharyngeal carcinoma allowed No concurrent malignancy Not pregnant or lactating Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: No prior chemotherapy for metastatic or recurrent disease Prior induction or adjuvant chemotherapy concurrent with radiation therapy allowed No prior treatment with paclitaxel Endocrine therapy: Not specified Radiotherapy: See Chemotherapy Surgery: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Veterans Affairs Medical Center - Palo Alto
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Decatur
country: United States
facility: Veterans Affairs Medical Center - Atlanta (Decatur)
state: Georgia
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Veterans Affairs Medical Center - Chicago (Lakeside)
state: Illinois
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: East Orange
country: United States
facility: Veterans Affairs Medical Center - East Orange
state: New Jersey
city: Hackensack
country: United States
facility: CCOP - Northern New Jersey
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Cancer Center
state: New York
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Cancer Center
state: Tennessee
city: Pretoria
country: South Africa
facility: Pretoria Academic Hospital
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Barbara A. Murphy, MD
role: STUDY_CHAIR
References: