S0007 - Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: cisplatin; Drug: fluorouracil; Drug: paclitaxel

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00006248

S0007 (Other Identifier)

CDR0000068180

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent head and neck cancer.

Full description

OBJECTIVES:

• Determine the overall survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with paclitaxel, cisplatin, and fluorouracil.
• Determine response (unconfirmed, confirmed, complete, and partial) and time to treatment failure in patients with measurable disease treated with this regimen.
• Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 30 minutes on day 1 and fluorouracil IV over 24 hours on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 3 additional courses beyond CR.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 12 months.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck

  • Metastatic at diagnosis or persistent, metastatic, or recurrent after surgery and/or radiotherapy
  • Relapse after prior induction or adjuvant therapy allowed

• No newly diagnosed nonmetastatic disease

• Measurable or nonmeasurable disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 50 mL/min

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No grade 2 or greater sensory neuropathy
• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent biologic therapy

Chemotherapy:

• See Disease Characteristics
• At least 6 months since prior carboplatin or cisplatin induction or adjuvant chemotherapy
• No more than 1 prior induction or adjuvant chemotherapy regimen
• No prior chemotherapy for recurrent or newly diagnosed metastatic disease
• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent anticancer hormonal therapy

Radiotherapy:

• See Disease Characteristics
• At least 28 days since prior radiotherapy and recovered
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• At least 28 days since prior surgery and recovered

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)