Everolimus, Carboplatin, and Paclitaxel in Locally Advanced Head and Neck Cancer That Cannot Be Removed by Surgery

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus together with carboplatin and paclitaxel in treating patients with locally advanced head and neck cancer that cannot be removed by surgery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Everolimus; Paclitaxel; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

• Locally advanced disease (T4 N0-N3 disease)

• Unresectable disease OR resectable disease with surgery contra-indication

• No stage I, II, III, or IVc disease

• Measurable lesions defined as those accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan

• No known brain metastases (cerebral CT scan is not required if no symptom is present)

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Life expectancy > 3 months

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9 g/dL

• Total bilirubin ≤ 1.25 times upper limit of normal (ULN)

• Transaminases ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 5 times ULN

• Creatinine clearance ≥ 60 mL/min

• Glycemia ≤ 1.5 times ULN

• Cholesterol level ≤ 7.30 mmol/L

• Serum total protein normal

• Oxygen saturation > 88%

• Able to swallow pills

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• No preexisting neuropathy ≥ grade 2

• No uncontrolled disease including any of the following:

• Diabetes

• Hypertension

• Symptomatic congestive heart or pulmonary failure

• Renal or hepatic chronic disease

• Severe infectious disease

• No active hemorrhagic syndrome

• No prior history of cancer within the past 5 years, except in situ cervical cancer and basal cell skin carcinoma

• No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

• Registration in a national health care system (CMU included)

• Not eligible for organ preservation program

PRIOR CONCURRENT THERAPY:

• No prior therapy for this cancer

• No prior chemotherapy unless received for treatment of another primary tumor considered in remission

• No prior investigational drug

• More than 30 days since prior participation in another therapeutic trial

• No prior or concurrent radiotherapy (except anterior radiotherapy) unless received for treatment of another primary tumor considered in remission

• No concurrent CYP3A4 strong inhibitors (e.g., azole antimycotics [itraconazole, ketoconazole], HIV protease inhibitor [ritonavir], erythromycin, anti-epileptic drugs [phenytoin, carbamazepine])

• No concurrent anti-coagulant therapy