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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Fluorouracil; Paclitaxel

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