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

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Brief Title

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

Official Title

ZD1839 (NSC #715055, IND #61187) With Induction Paclitaxel And Carboplatin Followed By Either Radiation Or Concomitant Radiation With Weekly Paclitaxel And Carboplatin In Stage III Non-Small Cell Lung Cancer, A Phase II Study

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.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine whether ZD1839 (gefitinib) at 250 mg orally every day administered
      concomitantly with radiotherapy after induction treatment consisting of paclitaxel,
      carboplatin, and ZD1839 among patients with inoperable stage III non-small cell lung cancer
      and Common Terminology Criteria (CTC) performance status 2 or poor risk performance status
      0-1 is tolerable.

      II. To determine whether ZD1839 at 250 mg orally every day administered concomitantly with
      paclitaxel, carboplatin, and radiation after induction treatment consisting of paclitaxel,
      carboplatin, and ZD1839 among patients with inoperable stage III non-small cell lung cancer
      and CTC performance status 0-1 is tolerable.

      III. To determine the overall response rate, failure-free survival, and survival after
      treatment with induction chemotherapy with daily ZD1839, concomitant radiotherapy and daily
      ZD1839, and post-radiotherapy single agent daily ZD1839 among patients with CTC performance
      status 2 or poor risk performance status 0-1 and inoperable stage III non-small cell lung
      cancer.

      IV. To determine the overall response rate, failure-free survival, and survival after
      treatment with induction chemotherapy and daily ZD1839, concomitant chemoradiotherapy and
      daily ZD1839, and post-radiotherapy single agent daily ZD1839 among patients with CTC
      performance status 0-1 and inoperable stage III non-small cell lung cancer.

      V. To determine if elevated circulating epidermal growth factor receptor (EGFR) levels prior
      to treatment, as determined by either quantitative polymerase chain reaction (PCR) or direct
      enzyme-linked immunosorbent assay (ELISA) measurement, may predict for response to therapy
      with EGFR inhibitors.

      OUTLINE:

      All patients receive induction therapy comprising paclitaxel IV over 3 hours followed by
      carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
      Patients then receive therapy based on their assigned stratum.

      STRATUM I: Patients receive gefitinib orally (PO) daily for 7 weeks. Patients also undergo
      concurrent radiotherapy once daily 5 days a week for 7 weeks.

      STRATUM II: 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.

      After completion of study treatment, patients are followed up every 3 months for 1 year and
      then every 6 months for 2 years.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall survival (Stratum I)


Condition

Adenocarcinoma of the Lung

Intervention

paclitaxel

Study Arms / Comparison Groups

 Stratum I (gefitinib, radiotherapy)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

144

Start Date

May 2002


Primary Completion Date

March 2006

Eligibility Criteria

        Inclusion Criteria:

          -  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

                    -  Cystic lesions

                    -  Tumor lesions situated in a previously irradiated area

          -  PRIOR THERAPY

               -  >= 2 weeks since formal exploratory thoracotomy.

               -  No prior chemotherapy or radiation therapy for NSCLC

          -  CTC performance status 0-2

          -  No "currently active" second malignancy other than non-melanoma skin cancers; patients
             are not considered to have a "currently active" malignancy if they have completed
             therapy and are considered by their physician to be at less than 30% risk of relapse

          -  Non-pregnant and non-nursing because of significant risk to the fetus/infant

          -  No patients with uncontrolled intercurrent illness including, but not limited to,
             ongoing or active infection, symptomatic congestive heart failure, unstable angina
             pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
             limit compliance with study requirements

          -  No patients with chronic gastrointestinal disorders including liver disease, diarrheal
             or emetic disorders, or malabsorptive conditions which could worsen toxicity or limit
             efficacy of ZD1839

          -  No cytochrome P450 3A4 (CYP3A4) inducers within 7 days prior to starting protocol
             therapy and while on protocol treatment. CYP3A4 inducers: phenytoin, carbamazepine,
             barbiturates, rifampicin, dexamethasone, and St John's Wort; single doses of
             dexamethasone used as an antiemetic are permitted

          -  No human immunodeficiency virus (HIV)-positive patients receiving combination
             anti-retroviral therapy

          -  Granulocytes >= 1,500/ul

          -  Platelets >= 100,000/ul

          -  Calculated creatinine clearance >= 20 cc/min

          -  Bilirubin < 1.5 mg/dl

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 2
             x upper limit of normal (ULN)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Neal Ready, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00040794

Organization ID

NCI-2012-02821

Secondary IDs

CALGB-30106

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Neal Ready, Principal Investigator, Cancer and Leukemia Group B


Verification Date

June 2013