Combination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

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Brief Title

Combination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

Official Title

A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed by Maintenance Therapy With ZD1839 (NSC-715055) or Placebo in Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer

Brief Summary

      Randomized phase III trial to compare the effectiveness of combination chemotherapy plus
      radiation therapy with or without gefitinib in treating unresectable stage III non-small cell
      lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing
      so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Biological therapies such as gefitinib may interfere with the growth of the tumor cells and
      slow the growth of tumors. It is not yet known whether combination chemotherapy plus
      radiation therapy is more effective with or without gefitinib in treating non-small cell lung
      cancer
    

Detailed Description

      OBJECTIVES:

      I. To assess whether maintenance therapy with ZD1839 as compared to placebo following
      induction cisplatin/etoposide/radiotherapy plus consolidation docetaxel improves overall
      survival and progression-free survival in patients with unresectable Stage III non-small cell
      lung cancer (NSCLC).

      II. To describe the toxicity profile of long term administration of ZD1839. III. To obtain
      samples for correlative studies.

      OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
      according to performance status (0 vs 1), stage (stage IIIA vs IIIB), measurability of lesion
      (measurable vs nonmeasurable), and histologic subtype (squamous vs nonsquamous).

      Patients receive induction therapy comprising cisplatin IV over 1 hour on days 1, 8, 29, and
      36 and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning within 24 hours after
      starting chemotherapy, patients receive concurrent induction radiotherapy 5 days a week for 5
      weeks and then boost radiotherapy 5 days a week for 1.5 weeks.

      Beginning approximately 4-8 weeks after completion of chemoradiotherapy, patients with stable
      or responding disease receive consolidation therapy comprising docetaxel IV over 1 hour on
      day 1. Treatment repeats every 21 days for 3 courses.

      Patients with stable or responding disease are randomized to one of two treatment arms for
      maintenance therapy. Patients begin maintenance therapy approximately 4-7 weeks after
      completion of consolidation therapy.

      Arm I: Patients receive oral gefitinib daily.

      Arm II: Patients receive oral placebo daily. In both arms, maintenance therapy continues for
      a maximum of 5 years in the absence of disease progression or unacceptable toxicity.

      Patients are followed every 6 months for 5 years and then annually for 5 years.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Overall Survival


Condition

Adenocarcinoma of the Lung

Intervention

cisplatin

Study Arms / Comparison Groups

 Arm I (gefitinib, combination chemotherapy, radiation)
Description:  Patients receive induction therapy comprising cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning within 24 hours after starting chemotherapy, patients receive concurrent induction radiotherapy 5 days a week for 5 weeks and then boost radiotherapy 5 days a week for 1.5 weeks.
Beginning approximately 4-8 weeks after completion of chemoradiotherapy, patients with stable or responding disease receive consolidation therapy comprising docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 3 courses.
Patients with stable or responding disease are randomized to one of two treatment arms for maintenance therapy. Patients begin maintenance therapy approximately 4-7 weeks after completion of consolidation therapy.
Patients receive oral gefitinib daily.

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

840

Start Date

June 2001


Primary Completion Date

February 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Either histologic or cytologic proof of a newly diagnosed single, primary bronchogenic
             non-small cell lung cancer is required (adenocarcinoma, non-lobar and non-diffuse
             bronchioloalveolar cell carcinoma, large cell carcinoma, or squamous cell carcinoma);
             a biopsy with histology is preferred, but cytology is allowed; histology or cytology
             from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a
             separate distal primary lesion is clearly evident on radiographs (i.e., a second
             biopsy will not be required)

          -  Patients with brain metastases are ineligible; all patients must have a pretreatment
             CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to
             registration

          -  Patients with two or more parenchymal lesions on same or opposite sides of the lung
             are ineligible

          -  Patients must have unresectable Stage IIIA (N2) or Stage IIIB disease and also satisfy
             the following criteria:

               -  Unresectable Stage IIIA (N2) patients must satisfy the criteria:

                    -  N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or
                       X-ray, such that, in the opinion of the treating investigator, the patient
                       is not a candidate for induction chemotherapy or chemoradiotherapy followed
                       by surgical resection

               -  If Stage IIIA (N2), the N2 status must be documented by any one of the following
                  methods:

                    -  Histologic or cytologic proof of N2 disease by exploratory thoracotomy,
                       thoracoscopy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang
                       needle biopsy, or fine needle aspiration (FNA) under bronchoscopic or CT
                       guidance or other method

                    -  Node positivity by FDG-PET scan

                    -  Nodes > 3 cm on CT scan

                    -  Paralyzed left true vocal cord with separate left lung primary distinct from
                       AP window nodes on CT scan

               -  Stage IIIB patients must satisfy the following criteria; documentation of N3 or
                  T4 status may be obtained by one or more of the following:

                    -  Pathologically documented or radiographically documented positive N3 nodes;
                       patients with positive supraclavicular or scalene lymph nodes must not have
                       disease extending up into the cervical region

                         -  Fine needle aspiration, core needle biopsy or excisional biopsy or
                            supraclavicular N3 nodes

                         -  Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy,
                            mediastinotomy or thoracotomy

                         -  Fine needle aspiration, core needle or Wang needle biopsy under Ct or
                            bronchoscopic fluoroscopic guidance of enlarged contralateral N3
                            mediastinal nodes

                         -  Contralateral mediastinal nodes > 3 cm on CT scan

                         -  Node positivity by FDG-PET scan

                         -  Right sided primary with paralyzed left true vocal cord OR

                    -  Any of the following T4 lesions: Tumor of any size that invades any of the
                       following: mediastinum, heart, great vessels, trachea, esophagus, vertebral
                       body or carina

                         -  Written documentation of type of T4 extent by attending surgeon on
                            either the operative report or as an addendum in the notes section of
                            the prestudy form if patient has had an exploratory thoracotomy or
                            thoracoscopy

                         -  T4 involvement of trachea or carina by direct bronchoscopic
                            visualization, documented on bronchoscopy report or as an addendum in
                            the notes section of the prestudy form

                         -  T4 involvement of heart, esophagus, aorta or vertebral body documented
                            by CT scan, MRI or transesophageal ultrasound

                         -  T4 involvement of the mediastinum may also be accepted by CT or MRI
                            criteria if, in absence of the above organ involvement, there is soft
                            tissue extension directly into the mediastinal space; radiographic
                            criteria for involvement of main pulmonary artery or vein is allowed
                            only if there is a mediastinal soft tissue mass

          -  Patients must not have malignant pleural effusions; NOTE: the only exception is
             pleural effusion only on CT scan (and not visible on CXR) OR deemed too small to tap

          -  Patients with pericardial effusions are ineligible

          -  All patients must have measurable or non-measurable disease documented by CT, MRI,
             X-ray or physical exam; measurable disease must be assessed within 28 days prior to
             registration and non-measurable disease assessed within 42 days prior to registration;
             pleural effusions and laboratory parameters are not acceptable as the only evidence of
             disease

          -  Patients must not have received any prior chemotherapy or radiotherapy for lung
             cancer; patients must not have had a previous surgical resection; however, patients
             may have undergone exploratory thoracotomy, mediastinoscopy, excisional biopsy or
             similar surgery for the purpose of determining diagnosis, stage, or potential
             resectability or newly diagnosed lung tumor

          -  Patients must have a measured or calculated creatinine clearance >= 50 cc/min

          -  The pre-registration FEV1 must be either >= 2.0 liters, OR if < 2.0 liters, the
             predicted FEV1 of the contralateral lung must be > 800 cc based on the quantitative
             split function testing within 42 days prior to registration

          -  WBC >= 3,000/ul

          -  ANC >= 1,200/ul

          -  Platelet count >= 100,000/ul

          -  All patients must have a CT of upper abdomen to exclude metastatic disease involving
             the contralateral chest, liver or adrenals (if chest CT is performed including
             complete liver and adrenals in the report, a separate CT of upper abdomen is not
             necessary) within 42 days prior to registration

          -  All patients must have a Zubrod Performance Status of 0-1

          -  Patients must have an EKG within 42 days prior to registration

          -  Institutions must have received IRB approval for S9925; Southwest Oncology Group,
             NCIC-CTG and CTSU patients must be offered participation in S9925 (the Lung Cancer
             Specimen Repository); patients registered by other groups may be offered participation
             in S9925 (at the discretion of the participating group)

          -  No prior malignancy is allowed except for adequately treated basal cell or squamous
             cell skin cancer, in situ cervical cancer, or other cancer for which the patient has
             been disease-free for five years

          -  If day 28 of 42 falls on a weekend or holiday, the limit may be extended to the next
             working day

          -  Pregnant or nursing women may not participate in this trial because of the increased
             risk of fetal harm including fetal death from the chemotherapeutic agents; women/men
             of reproductive potential may not participate unless they have agreed to use an
             effective contraceptive method

          -  Patients must be informed of the investigational nature of this study and must sign
             and give written informed consent in accordance with institutional and federal
             guidelines

          -  At the time of patient registration, the treating institution's name and ID number
             must be provided to the Data Operations Center in Seattle in order to ensure that the
             current (within 365 days) date of institutional review board approval for this study
             has been entered into the data base
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Karen Kelly, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00020709

Organization ID

NCI-2012-03041

Secondary IDs

S0023

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Karen Kelly, Principal Investigator, Southwest Oncology Group


Verification Date

February 2013