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Induction Chemotherapy With Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage IVA/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC)

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer; Squamous Cell Cancer

Intervention: Afatinib, Ribavirin, and weekly carboplatin/paclitaxel (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
David Pfister, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Summary

This study seeks to develop a new induction chemotherapy regimen which is a combination of two pill drugs taken by mouth and two drugs given by vein. This is a phase I study, which means that the primary goal is to establish the recommended dose of an investigational drug when added to chemotherapy. The researchers wish to evaluate the effects, good and bad, of the investigational drug.

Clinical Details

Official title: Phase I Study of Induction Chemotherapy With Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage IVA/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

maximum tolerated dose (For Dose Escalation Portion of the study)

expression of PTPN13 (For Expansion Cohort only)

Secondary outcome:

safety and tolerability (toxicity)

objective response rate

pharmacokinetics

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Department of Pathology at MSKCC confirmation of diagnosis of oropharynx squamous

cell cancer, stage IVA/IVB, that is HPV associated. Evidence of HPV can be p16 immunohistochemistry and/or HPV in situ hybridization positive test result on tumor tissue, either at MSKCC or other CLIA-approved lab.

- Age ≥ 18 years of age

- Karnofsky Performance Status ≥ 80

- Adequate organ function, as follows:

Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1. 5 X 109/L, platelets ≥ 160 X 109/L, hemoglobin ≥ 12 g/dL Hepatic: total bilirubin within normal limits (≤ 1. 0 mg/dL); alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1. 5 X ULN (upper limit of normal) Renal: Serum creatinine ≤ 1. 3 mg/dL. Patients with serum creatinine > 1. 3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 55 mL/min based on the standard Cockroft and Gault formula.

- Patients of childbearing potential must have a negative serum pregnancy test within

14 days of treatment. Patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.

- Ability to swallow oral medication.

- Expansion Cohort only: At least one unstained slide from pre-treatment diagnostic

biopsy or fine needle aspirate must be available for correlative immunohistochemistry study. Exclusion Criteria:

- Prior chemotherapy or radiation for tonsillar or base of tongue squamous cell cancer

- History of hemolytic anemia or thalassemia

- Active infection or serious underlying medical condition that would impair the

patient's ability to receive protocol treatment.

- Current therapeutic anticoagulation with Coumadin (warfarin)

- Current or prior treatment with ribavirin

- Known active Hepatitis B or C

- Any prior documented history of transient ischemic attack (TIA) or cerebrovascular

accident (CVA)

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- Clinically significant peripheral vascular disease

- Inability to discontinue any of the following potent P-gp inhibitors (cyclosporine,

erythromycin, ketoconazole, itraconazole, quinidine, phenobarbital salt with quinidine, ritonavir, valspodar, verapamil) or inducers (St John's wort, rifampicin).

- Known pre-existing interstitial lung disease.

- Presence of poorly controlled gastrointestinal disorders that could affect the

absorption of the trial drug (e. g. Crohn's disease, ulcerative colitis, malabsorption, or CTC grade ≥2 diarrhea of any etiology) based on treating physician assessment.

Locations and Contacts

Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge, New Jersey 07939, United States

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States

Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: November 2012
Last updated: May 19, 2015

Page last updated: August 23, 2015

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