Study of TARCEVA (Erlotinib) as Adjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT01515137 | Completed Phase 1 DMC

• 1 other identifier: 05-045
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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 in the adjuvant setting. Since implementing the trial in late 2005, The investigators have encountered significant obstacles to implementing the adjuvant therapy phase of the trial.

1. 1.disease recurrence
2. 2.patient refusal to take the agent
3. 3.patient refusal to travel to Pittsburgh for clinical evaluations.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck; Locally Advanced Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Phase II Study of TARCEVA (Erlotinib) as Adjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma with Evaluation of Neoadjuvant Biomarker Modulation with TARCEVA vs. TARCEVA Plus Sulindac

  Primary objective centered around concept of tumor biomarkers which may be modulated by EGFR \& Cox-2 inhibitors \& may serve as future therapeutic targets for therapy. Patients on this trial to be randomly assigned to 1 of 3 arms in the 2 week pre-operative period. A panel of biomarkers will be obtained by biopsy prior to pre-operative therapy and again at surgery. Biomarkers will be examined for modulation in the 2-week pre-operative period, for group differences, for treatment effects and for further understanding of protein signaling pathways.

  10 years

Study Arms (3)

Arm A erlotinib plus sulindac

EXPERIMENTAL

erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A),

Drug: Erlotinib plus sulindac

Arm B erlotinib

EXPERIMENTAL

erlotinib (150 mg PO QD) (Arm B)

Drug: Erlotinib

Arm C

EXPERIMENTAL

placebo (for Erlotinib) QD (Arm C).

Drug: Placebo

Interventions

Erlotinib DRUG

Erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A), Erlotinib (150 mg PO QD) (Arm B) or placebo (for Erlotinib) QD (Arm C).

Also known as: Tarceva

Arm B erlotinib

Erlotinib plus sulindac DRUG

Erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A), Erlotinib (150 mg PO QD) (Arm B) or placebo (for Erlotinib) QD (Arm C).

Also known as: Tarceva

Arm A erlotinib plus sulindac

Placebo DRUG

Erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A), Erlotinib (150 mg PO QD) (Arm B) or placebo (for Erlotinib) QD (Arm C).

Also known as: Tarceva

Arm C

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• OSI Pharmaceuticals: collaborator

Study Sites (1)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Erlotinib Hydrochloride; Sulindac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Jennifer Grandis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 23, 2012
• Study Start: November 1, 2005
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 28, 2023

Record last verified: 2016-01

Locations

US (1)