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Phase II Randomized Study of Taxol (PACLITAXEL), Paraplatin (Carboplatin), and Radiation Therapy for Locally Advanced Inoperable Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Phase II Randomized Study of Taxol (PACLITAXEL), Paraplatin (Carboplatin), and Radiation Therapy for Locally Advanced Inoperable Non-Small Cell Lung Cancer

OBJECTIVES: I. Compare survival of patients with stage IIIA or IIIB unresectable non-small
cell lung cancer treated with one of three different combined modality regimens of
paclitaxel, carboplatin, and radiotherapy. II. Compare the safety and toxicity of these
treatment regimens in these patients. III. Compare the relapse free survival rate in these
patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three
treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over
30 minutes on day 1 every 3 weeks for 2 courses, followed by radiotherapy 5 times a week for
7 weeks beginning on day 42. Arm II: Patients receive paclitaxel and carboplatin as in arm I
followed by radiotherapy 5 times a week, paclitaxel IV over 1 hour, and carboplatin IV over
30 minutes weekly for 7 weeks beginning on day 42. Arm III: Patients receive paclitaxel IV
over 1 hour and carboplatin IV over 30 minutes weekly and radiotherapy 5 times a week for 7
weeks beginning on day 1, followed by paclitaxel IV over 3 hours and carboplatin IV over 30
minutes every 3 weeks for 2 courses beginning 3 weeks after concurrent chemotherapy and
radiotherapy. Patients are followed every 3 months for 2 years, every 4 months for 2 years,
and then annually thereafter.

PROJECTED ACCRUAL: A total of 264 patients (88 per treatment arm) will be accrued for this
study within 20 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer (NSCLC) Stage IIIA (T1-2, N2, M0 or T3, N1-2, M0) if not medically operable Stage
IIIB (any T, N3, M0 or T4, any N, M0) Radiographic evidence of mediastinal lymph nodes at
least 2.0 cm in the largest diameter sufficient to stage N2 or N3 disease If largest
mediastinal node is less than 2.0 cm in diameter and is the basis for stage III disease,
then at least one node must be histologically or cytologically confirmed positive Any of
the following histologies allowed: Squamous cell carcinoma Adenocarcinoma (including
bronchoalveolar cell) Large cell anaplastic carcinoma (including giant and clear cell
carcinomas) Poorly differentiated NSCLC No metastatic disease Patients with tumors
adjacent to a vertebral body allowed if all gross disease can be encompassed in the
radiation boost field (boost volume must be limited to less than 50% of the ipsilateral
lung volume) Pleural effusions that are a transudate, cytologically negative, and
non-bloody are allowed if tumor can be encompassed within reasonable field of radiotherapy
Pleural effusions that can be seen on chest CT but not on chest x-ray and are too small to
tap are allowed No brain metastases by MRI or CT scan No prior total surgical resection

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet
count at least 100,000/mm3 Hemoglobin greater than 8 g/dL (transfusion or epoetin alfa
allowed) Hepatic: Bilirubin less than 1.5 times normal Renal: Creatinine clearance greater
than 50 mL/min Cardiovascular: No history of uncontrolled serious cardiac disease No
myocardial infarction within the past 6 months No congestive heart failure No unstable
angina No clinically significant pericardial effusion or arrhythmia Pulmonary: FEV1
greater than 800 mL Post obstructive pneumonia allowed Other: No other active concurrent
or prior malignancy within the past 5 years except nonmelanomatous skin cancer or
carcinoma in situ of the cervix No other serious medical or psychiatric illness that would
preclude study No active serious infection No prior significant allergic reactions to
drugs containing Cremophor (e.g., cyclosporine or vitamin K) No weight loss of more than
10% within 3 months prior to diagnosis Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors
(i.e., filgrastim (G-CSF) or sargramostim (GM-CSF)) No concurrent immunotherapy Concurrent
epoetin alfa allowed Chemotherapy: No prior systemic chemotherapy No other concurrent
chemotherapy Endocrine therapy: No concurrent hormonal agents except for nondisease
related conditions (e.g., insulin for diabetes) Concurrent steroids administered for
adrenal failure or septic shock allowed Concurrent glucocorticosteroids as antiemetics
allowed Radiotherapy: No prior radiotherapy to the thorax Surgery: See Disease
Characteristics At least 3 weeks since formal exploratory thoracotomy and recovered At
least 1 week since prior diagnostic thoracoscopy Other: No other concurrent anticancer

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Nathan Levitan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Morristown Memorial Hospital Morristown, New Jersey  07962-1956
University Hospitals of Cleveland Cleveland, Ohio  44106
Cancer Institute of New Jersey New Brunswick, New Jersey  08901