Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer

NCT00040794 | Completed Phase 2

• 4 other identifiers: NCI-2012-02821CALGB-30106CDR0000069407U10CA031946
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II clinical trial studies how well combining different regimens of chemotherapy and gefitinib with radiation therapy work in treating patients with stage III non-small cell lung cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of non-small cell lung cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving different regimens of combination therapy together with gefitinib and radiation therapy may be an effective treatment for non-small cell lung cancer.

Conditions

Adenocarcinoma of the Lung; Adenosquamous Cell Lung Cancer; Bronchoalveolar Cell Lung Cancer; Large Cell Lung Cancer; Squamous Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (7)

• Overall survival (Stratum I)

  Kaplan-Meier curves will be used to describe overall survival in each stratum.

  From randomization until death or last known follow-up, assessed up to 10 months

• Overall survival (Stratum I)

  Kaplan-Meier curves will be used to describe overall survival in each stratum.

  From randomization until death or last known follow-up, assessed up to 13 months

• Overall survival (Stratum II)

  Kaplan-Meier curves will be used to describe overall survival in each stratum.

  From randomization until death or last known follow-up, assessed up to 14.5 months

• Toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

  The frequency of toxicity occurrence will be tabulated by the most severe occurrence.

  Up to 3 years

• Failure-free survival

  Kaplan-Meier curves will be used to describe failure-free survival in each stratum. Within each treatment group, the pattern of treatment failure (local, distant, regional) will be summarized.

  Time between randomization and disease progression, death, or last known follow-up, assessed up to 3 years

• Response to induction treatment

  Summarized by treatment group. Exact binomial confidence intervals will be computed for these response rates.

  Up to 3 years

• Overall response

  Overall response to the full treatment regimen will be summarized by treatment group. Exact binomial confidence intervals will be computed for these response rates.

  Up to 3 years

Study Arms (2)

Stratum I (gefitinib, radiotherapy)

EXPERIMENTAL

Patients receive gefitinib orally (PO) daily for 7 weeks. Patients also undergo concurrent radiotherapy once daily 5 days a week for 7 weeks. Patients then receive gefitinib PO daily in the absence of disease progression or unacceptable toxicity.

Drug: gefitinib; Radiation: radiation therapy; Other: laboratory biomarker analysis

Stratum II (gefitinib, radiotherapy, chemotherapy)

EXPERIMENTAL

Patients receive gefitinib and radiotherapy as in stratum I concurrently with paclitaxel IV over 1 hour followed by carboplatin over 30 minutes once weekly for 7 weeks. Patients then receive gefitinib PO daily in the absence of disease progression or unacceptable toxicity.

Drug: paclitaxel; Drug: carboplatin; Drug: gefitinib; Radiation: radiation therapy; Other: laboratory biomarker analysis

Interventions

paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol

Stratum II (gefitinib, radiotherapy, chemotherapy)

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Stratum II (gefitinib, radiotherapy, chemotherapy)

gefitinib DRUG

Given PO

Also known as: Iressa, ZD 1839

Stratum I (gefitinib, radiotherapy); Stratum II (gefitinib, radiotherapy, chemotherapy)

radiation therapy RADIATION

Undergo radiotherapy

Also known as: irradiation, radiotherapy, therapy, radiation

Stratum I (gefitinib, radiotherapy); Stratum II (gefitinib, radiotherapy, chemotherapy)

laboratory biomarker analysis OTHER

Optional correlative studies

Stratum I (gefitinib, radiotherapy); Stratum II (gefitinib, radiotherapy, chemotherapy)

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 non-small cell lung cancer (NSCLC), including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas)
• ELIGIBLE DISEASE STAGES: Inoperable IIIA and selected IIIB
• Generally, patients entered must be considered unresectable or inoperable; patients with T1 or T2, N2 disease are eligible; patients with T3, N2 or T4, N0-N2 disease are eligible if based on the closeness to the carina, invasion of the mediastinum or invasion of the chest wall; patients with T3, N0-N1 disease are not eligible; patients must be M0 (M1 patients are not eligible)
• Patients with direct invasion of vertebral body are ineligible
• Patients with tumors adjacent to a vertebral body are eligible, unless there is demonstrable bone invasion, as long as all gross disease can be encompassed in the radiation boost field in accordance with the homogeneity criteria
• Patients with contralateral mediastinal disease (N3) are eligible if all gross disease can be encompassed in the radiation boost field in accordance with the homogeneity criteria; patients with scalene, supraclavicular, or contralateral hilar node involvement are ineligible
• Patients with a pleural effusion, which is a transudate, cytologically negative and non-bloody, are eligible if the radiation oncologist feels the tumor can be encompassed within a reasonable field of radiotherapy. Patients with exudative, bloody, or cytologically malignant effusions are not eligible; if a pleural effusion can be seen on the chest computed tomography (CT) but not on chest x-ray (CXR) and is too small to tap, the patient will be eligible; a pleural effusion appearing only after a thoracotomy or other invasive thoracic procedure was attempted will not make a patient ineligible
• PATIENTS MUST HAVE MEASURABLE DISEASE
• Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as ≥10 mm with spiral CT scan
• Lesions that are not considered measurable include the following:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Abdominal masses that are not confirmed and followed by imaging techniques

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar; Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; Taxes; Carboplatin; Gefitinib; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Coordination Complexes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics; Physical Phenomena

Study Officials

• Neal Ready

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: March 1, 2006
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (1)