TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

NCT00563784 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 2005-1023NCI-2012-01761W81XWH-05-2-0027
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find out if erlotinib given with chemotherapy and radiation therapy can help to control NSCLC. The safety of this combination treatment will also be studied. Researchers will also test the tissue from your earlier biopsy to measure the levels of epidermal growth factor receptor (EGFR). The purpose of EGFR testing is to learn about any link between various forms of EGFR and your response to treatment with erlotinib.

Conditions

Non-Small Cell Lung Cancer; Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Lung Cancer; Squamous Cell Carcinoma; Adenocarcinoma; Bronchoalveolar Cell Carcinoma; Large Cell Anaplastic Carcinoma; Giant Cell Carcinoma; Clear Cell Carcinoma; Erlotinib; Erlotinib Hydrocholoride; OSI-774; Tarceva; Carboplatin; Paraplatin; Paclitaxel; Taxol; NSCLC

Outcome Measures

Primary Outcomes (1)

• Time To First Disease Progression

  Primary Endpoints is efficacy of concurrent erlotinib and chemoradiation as measured by time to progression. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. All patients will be evaluated by followed up one month after treatment, once a month until recovery from treatment related toxicities, then every 3 months for 2 years, then every 4 months for 2 years (total of 4 years), then annually up to 5 years.

  From date of registration until the date of first documented progression or death from any cause, or lost to follow up, whichever came first, assessed up to 5 years.

Secondary Outcomes (1)

• Overall Survival and Disease Local Control Rate

  OS: From date of registration until the date of first documented death or lost to follow up, whichever came first, accessed up to 5 years. DLC: From date of registration until the date of first documented local disease recurrence, accessed up to 5 years.

Study Arms (1)

Erlotinib + Paclitaxel + Carboplatin

EXPERIMENTAL

Oral Erlotinib 150 mg daily + Paclitaxel 45 mg/m\^2 by vein weekly + Carboplatin 2 AUC by vein weekly and Radiation Therapy 63 GY/35 fractions for 7 weeks cycles

Drug: Erlotinib; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy

Interventions

Erlotinib DRUG

150 mg by mouth daily for 7 Weeks

Also known as: Tarceva, OSI-774, Erlotinib Hydrochloride

Erlotinib + Paclitaxel + Carboplatin

Carboplatin DRUG

2 AUC by vein weekly for 7 Weeks

Also known as: Paraplatin

Erlotinib + Paclitaxel + Carboplatin

Paclitaxel DRUG

45 mg/m\^2 by vein weekly for 7 Weeks

Also known as: Taxol

Erlotinib + Paclitaxel + Carboplatin

Radiation Therapy RADIATION

63 GY/35 fractions for 7 weeks (+/- 5 days)

Also known as: RT, Radiotherapy

Erlotinib + Paclitaxel + Carboplatin

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 documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas) and poorly differentiated (not otherwise specified, NOS) non-small cell lung cancer; totally resected tumors are excluded. ·
• Patients must be M0;
• Patients with Tl or T2 disease with N2 or T3N1-2 disease (Stage IIIA) are eligible if they are deemed inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable. Radiographic evidence of mediastinal lymph nodes \> 2.0 cm in the largest diameter is sufficient to stage N2 or N3 disease. If the largest mediastinal node is \< 2.0 cm in diameter and this is the basis for stage III disease, then at least one of the nodes must be proven positive cytologically or histologically;
• Measurable disease is required
• Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to \< 50% of the ipsilateral lung volume.
• Patients must be greater than or equal to 18 years of age;
• Patients with Zubrod performance status 0-1
• Adequate hematologic function defined as: ANC greater than or equal 1,500/mm\^3, platelets greater than or equal 100,000/mm\^3, and hemoglobin greater than or equal 9 g/dL (prior to transfusions); adequate hepatic function defined as: total bilirubin less than or equal to 1.5 mg/dl, SGOT or SGPT less than or equal to 3 x ULN, adequate renal function defined as a serum creatinine level less than or equal to 2.0 mg/dl, alkaline phosphatase less than or equal to 2.5 x ULN, glucose less than or equal to 2 x ULN;
• FEV1 with greater than or equal to 1000 cc;
• Patients with weight loss less than or equal to than \</= 10% over the past 3 months;
• Patients with a pleural effusion that is a transudate, cytologically negative and nonbloody are eligible if the radiation oncologists feel the tumor can still be encompassed within a reasonable field of radiotherapy. If a pleural effusion can be seen on the chest CT but not on CXR and is too small to tap, the patient is eligible.
• If patients had exploratory thoracotomy, they must have recovered from the procedure. Exploratory Thoracotomy and beginning of treatment should be within one month.
• Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \[i.e., who has had menses at any time in the preceding 24 consecutive months\]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for four weeks after completion of treatment.
• For women of childbearing potential, a urine or blood pregnancy test must be performed within 48 hours prior to the start of protocol treatment;
• Medical Oncology and Radiation Oncology consults and approval.

You may not qualify if:

• Prior systemic chemotherapy and/or thoracic radiotherapy for any reason and/or surgical resection of present cancer;
• Exudative, bloody, or cytologically malignant effusion or effusion that are exudative and/or bloody and are suggestive or malignant involvement.
• Prior therapy with any other drug that targets the EGFR pathway,
• Active pulmonary infection not responsive to conventional antibiotics;
• History of interstitial lung disease;
• History of severe COPD requiring greater than or equal to 3 hospitalizations over the past year;
• Significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncompensated congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication; patients with left ventricular ejection fraction (LVEF) below the institutional range of normal (50-70%) on a baseline multiple gated acquisition (MUGA) scan or echocardiogram.
• Patients with \> grade 1 neuropathy;
• Evidence of malignancy in the past 3 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers;
• Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant; women with a positive pregnancy test on enrollment or prior to study drug administration;
• Women of childbearing potential and male participants who are unwilling or unable to use an acceptable method of contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for four weeks after completion of treatment or those who are using a prohibited contraceptive method (methods with unknown efficacy).
• Patients who currently are participating in other clinical trials and/or who have participated in other clinical trials in the previous 30 days. Clinical trials involving administration of investigational agents or interfering with the safe conduct of this trial. All clinical trials would exclude observational trials which would not interfere with the endpoints of our study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Komaki R, Allen PK, Wei X, Blumenschein GR, Tang X, Lee JJ, Welsh JW, Wistuba II, Liu DD, Hong WK. Adding Erlotinib to Chemoradiation Improves Overall Survival but Not Progression-Free Survival in Stage III Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2015 Jun 1;92(2):317-24. doi: 10.1016/j.ijrobp.2015.02.005.

  PMID: 25968826 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Carcinoma, Squamous Cell; Adenocarcinoma; Carcinoma, Giant Cell; Adenocarcinoma, Clear Cell

Interventions

Erlotinib Hydrochloride; Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Results Point of Contact

• Title: Dr. Steven H. Lin/Radiation Oncology
• Organization: UT MD Anderson Cancer Center

shlin@mdanderson.org

713-563-8490

Study Officials

• Steven H. Lin, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: November 1, 2007
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-11

Locations

US (1)