AP5346 or Oxaliplatin in Treating Patients With Metastatic and/or Unresectable Recurrent Head and Neck Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as AP5346 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This randomized clinical trial is studying the dose of AP5346 to see how well it works compared with the dose of oxaliplatin in treating patients with metastatic and/or unresectable recurrent head and neck cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: National Cancer Institute (NCI)
• Treatments: Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary squamous cell carcinoma of the head and neck, including the oral cavity, oropharynx, hypopharynx, larynx, or nasopharynx

• Metastatic and/or unresectable locally recurrent disease for which no curative treatment is available

• Patients must not be candidates for surgical resection or radiotherapy with curative intent

• Histological documentation of relapse required, especially for locoregional recurrence or recurrence in a previously irradiated field

• Tumor(s) must be amenable to minimally invasive biopsy during the first course of treatment

• Must have evidence of progression or appearance of a new lesion after completion of radiotherapy, if biopsy site is in a previously irradiated field

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Absolute neutrophil count ≥ 2,000/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 10 g/dL

• Bilirubin < 1.5 times upper level of normal (ULN)

• Alkaline phosphatase (AP) ≤ 5 times normal (unless elevation is due to bone disease or bone metastasis in the absence of liver disease)

• AST and ALT ≤ 3 times ULN

• AST and ALT > 3 times ULN allowed provided AP ≤ 3 times ULN

• Blood urea < 1.5 times ULN

• Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min OR creatinine clearance by 24-hour urine collection normal

• Calcium normal

• No history of hypersensitivity reactions of any kind to cisplatin or carboplatin

• No other serious medical condition or psychiatric illness that would preclude the patient's ability to give informed consent or receive study treatment

• No symptomatic peripheral neuropathy ≥ grade 2

• No need for IV alimentation

• No other serious illness or medical condition, including, but not limited to, the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris or cardiac arrhythmia

• Significant neurologic or psychiatric disorders, including dementia or uncontrolled seizures

• Hypophosphatemia

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 weeks since prior and no other concurrent anticancer treatment (i.e., chemotherapy, chemoradiotherapy, or radiotherapy)

• At least 4 weeks since prior biologic therapy

• No prior oxaliplatin

• Prior cisplatin or carboplatin allowed

• No concurrent anticoagulants other than cardioprotective doses of aspirin, cyclooxygenase 1-inhibitory nonspecific anti-inflammatory drugs, or prophylactic low-dose heparin

• Concurrent bisphosphonates for hypercalcemia allowed provided the drug was initiated ≥ 3 months prior to study entry