S9902 Docetaxel Plus Carboplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
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 docetaxel plus carboplatin in treating patients who have metastatic or recurrent head and neck cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Combination of Docetaxel (Taxotere)/ Carboplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)|
- Overall Survival [ Time Frame: Weekly while on protocol treatment, then every 3 months for 1 year, then every 6 months for 2 years. ] [ Designated as safety issue: No ]Overall survival was defined as the duration from the date of registration to the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
- Progression-Free Survival [ Time Frame: Every 6 weeks until progression of disease. ] [ Designated as safety issue: No ]Progression-Free Survival was defined as the duration between the date of registration and the date of first documentation of progression of disease or death due to any cause. Progression of disease was defined as a 50% increase in the sum of products of perpendicular diameters of measurable lesions or an increase of at least 10 square centimeters, whichever was smaller, or clear worsening of non-measurable lesions in the opinion of the treating investigator, appearance of new lesions, reappearance of lesions that had previously disappeared, or symptomatic deterioration.
- Response [ Time Frame: Every 6 weeks while on protocol treatment. ] [ Designated as safety issue: No ]Response was defined as a confirmed or unconfirmed complete or partial response. A complete response (CR) was defined as disappearance of all disease. A partial response (PR) was defined as a 50% decrease or greater in the sum of perpendicular diameters of all measurable lesions. A CR or PR was defined as confirmed if there were two consecutive determinations at least 3 weeks apart.
|Study Start Date:||November 1999|
|Study Completion Date:||January 2007|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Assess the survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck receiving docetaxel and carboplatin. II. Assess time to treatment failure and response rate (unconfirmed and confirmed complete and partial response) in this patient population. III. Evaluate the toxicities of this regimen in this patient population.
OUTLINE: Patients receive docetaxel IV over 1 hour immediately followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 1 year, every 6 months for 2 years, then annually thereafter until death.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study over 18 months.