A Phase II Trial of Carboplatin Plus Paclitaxel in the Treatment of Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Phase II Trial of Carboplatin Plus Paclitaxel in the Treatment of Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Barbara A. Murphy, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000066059
NCT ID:
NCT00003206
Start Date:
April 1998
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage IV nasopharyngeal cancer
- recurrent nasopharyngeal cancer
- Head and Neck Neoplasms
- Nasopharyngeal Neoplasms
Name | Location |
|---|---|
| Stanford University Medical Center | Stanford, California 94305-5408 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
| University of Rochester Cancer Center | Rochester, New York 14642 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
| CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
| Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
| Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
