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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00563784
First received: November 21, 2007
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

The goal of this clinical research study is to find out if erlotinib given with chemotherapy and radiation therapy can help to control Non-Small Cell Lung Cancer (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.

Primary Objective:

Determine the feasibility of concurrent erlotinib and chemoradiation as measured by safety and compliance. Safety is measured by the rate of grade 3 or worse nonhematological toxicities occurring prior to the beginning of consolidation therapy (including all toxicities attributed to chemoradiation occurring within 90 days of the start of radiation therapy); compliance is defined as the completion of the treatment regimen with no more than minor variations.

Secondary Objectives:

  1. Investigate associations between EGFR expression and toxicity, response, overall survival, and progression
  2. Estimate overall survival of patients on the study regimen (one and two year rates, median survival).
  3. Estimate the time to disease progression of patients on the study regimen (one and two year rates)
  4. Estimate the treatment response rate of patients on the study regimen (complete and partial response rates)

Condition Intervention Phase
Non-Small Cell Lung Cancer
Lung Cancer
Drug: Erlotinib
Drug: Carboplatin
Drug: Paclitaxel
Radiation: Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Time to Disease Progression [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Time measured in months from treatment to disease progression, follow up every 6 months.


Estimated Enrollment: 48
Study Start Date: November 2007
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib + Paclitaxel + Carboplatin
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
150 mg by mouth daily for 7 Weeks
Other Names:
  • Tarceva
  • OSI-774
  • Erlotinib Hydrochloride
Drug: Carboplatin
2 AUC by vein weekly for 7 Weeks
Other Name: Paraplatin
Drug: Paclitaxel
45 mg/m^2 by vein weekly for 7 Weeks
Other Name: Taxol
Radiation: Radiation Therapy
63 GY/35 fractions for 7 weeks (+/- 5 days)
Other Names:
  • RT
  • Radiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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. ·
  2. Patients must be M0;
  3. 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;
  4. Measurable disease is required
  5. 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.
  6. Patients must be greater than or equal to 18 years of age;
  7. Patients with Zubrod performance status 0-1
  8. 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;
  9. FEV1 with greater than or equal to 1000 cc;
  10. Patients with weight loss less than or equal to than </= 10% over the past 3 months;
  11. 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.
  12. If patients had exploratory thoracotomy, they must have recovered from the procedure. Exploratory Thoracotomy and beginning of treatment should be within one month.
  13. 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.
  14. For women of childbearing potential, a urine or blood pregnancy test must be performed within 48 hours prior to the start of protocol treatment;
  15. Medical Oncology and Radiation Oncology consults and approval.
  16. Patients must sign a study-specific consent form prior to study entry.

Exclusion Criteria:

  1. Prior systemic chemotherapy and/or thoracic radiotherapy for any reason and/or surgical resection of present cancer;
  2. Exudative, bloody, or cytologically malignant effusion or effusion that are exudative and/or bloody and are suggestive or malignant involvement.
  3. Prior therapy with any other drug that targets the EGFR pathway,
  4. Active pulmonary infection not responsive to conventional antibiotics;
  5. History of interstitial lung disease;
  6. History of severe COPD requiring greater than or equal to 3 hospitalizations over the past year;
  7. 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.
  8. Patients with > grade 1 neuropathy;
  9. 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;
  10. 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;
  11. 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).
  12. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563784

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech, Inc.
Investigators
Principal Investigator: Ritsuko R. Komaki, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00563784     History of Changes
Other Study ID Numbers: 2005-1023, NCI-2012-01761
Study First Received: November 21, 2007
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Erlotinib
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014