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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


Phase 2
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival (Stratum I)

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Neal Ready

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02821

NCT ID:

NCT00040794

Start Date:

May 2002

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606