Status:
COMPLETED
Study of TARCEVA (Erlotinib) as Adjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
OSI Pharmaceuticals
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This trial was originally designed and powered to compare biomarker modulation in the neo-adjuvant setting (erlotinib versus erlotinib plus sulindac versus placebo) with clinical response to erlotinib...
Detailed Description
Head and neck squamous cell carcinoma (HNSCC) constitutes 3 percent of all malignancies and is the sixth most common malignancy worldwide. There will be an estimated 38,000 new cases and 11,000 deaths...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed, previously untreated HNSCC.
- Clinical stage II, III or IVA disease without distant metastasis, as defined by the American Joint Committee on Cancer Staging System, Sixth edition (See Appendix I).
- Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx will be included. Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors are NOT allowed.
- Macroscopic complete resection of the primary tumor must be planned.
- Patients will be willing to receive postoperative therapy with platinum and radiation if qualified based on criteria listed in treatment plan.
- Age 18 years.
- ECOG performance status 0-1 (See Appendix II).
- Adequate hematologic, renal and hepatic function, as defined by:
- Absolute neutrophil count (ANC) greater than 1,500/ul, platelets greater than 100,000/ul.
- Creatinine less than 1.5 x institutional upper limit of normal (ULN).
- Bilirubin less than 1.5 x ULN, AST or ALT 2.5 x ULN.
- Have signed written informed consent.
Exclusion
- Subjects who fail to meet the above criteria.
- Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy.
- Subjects with a ECOG performance status of 2 or worse.
- Evidence of distant metastasis.
- Any other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, DCIS or LCIS of the breast.
- Prior history of HNSCC.
- Prior therapy targeting the EGFR pathway.
- Known severe hypersensitivity to sulindac or other non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin.
- Any unresolved chronic toxicity greater than grade 2 from previous anticancer therapy (except alopecia), according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
- Incomplete healing from previous major surgery.
- Acute hepatitis, known HIV, or active uncontrolled infection.
- History of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months, untreated known coronary artery disease, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
- Any preexisting active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic are NOT excluded).
- Treatment with anticoagulants, except when used to maintain the patency of a central venous line.
- Uncontrolled peptic or gastric ulcer disease, or gastrointestinal bleeding within prior 6 months.
- Active alcohol abuse or other illness that carries a likelihood of inability to comply with study treatment and follow-up.
- Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01515137
Start Date
November 1 2005
End Date
September 1 2014
Last Update
March 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232