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

NCT00415298 | Unknown

• 2 other identifiers: CDR0000520463UCSD-HRPP-050275
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (6)

• Delivered-dose of platinum 24 hours after IV injection of a single dose of AP5346 vs a single dose of oxaliplatin

• Correlation of platinum accumulation in the tumor and tumor DNA with clinical response

• Correlation of platinum accumulation in the tumor and tumor DNA with molecular response as determined by GADD153 expression

• Quantification of expression of CTR1, ATP7A, and ATP7B in squamous cell carcinoma of the head and neck (SCCHN) tumors by immunohistochemistry

• Correlation of expression of CTR1, ATP7A, and ATP7B in SCCHN tumors with tumor platinum levels

• Toxicity of AP5346

Interventions

DACH polymer platinate AP5346 DRUG

oxaliplatin DRUG

gene expression analysis GENETIC

immunohistochemistry staining method OTHER

pharmacological study OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

ProLindac; Oxaliplatin; Gene Expression Profiling; Immunohistochemistry; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Genetic Techniques; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• William L. Read, MD

  University of California, San Diego

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2006
• First Posted: December 22, 2006
• Study Start: May 1, 2006
• Last Updated: January 10, 2014

Record last verified: 2007-05

Locations

US (1)