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A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed 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. Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.

Date & Status

Terminated

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma

- Squamous cell

- Adenocarcinoma

- Large cell undifferentiated

- Bronchoalveolar

- Non-small cell carcinoma not otherwise stated

- Unresectable stage IIIA

- Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on
computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule
out resectability

OR

- Stage IIIB disease without significant pleural effusion

- Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1
thoracentesis and is cytologically negative

- Metastases to contralateral, mediastinal, or supraclavicular nodes allowed

- Bidimensionally measurable or evaluable disease

- 18 and over

- ECOG performance status 0-1

- Adequate hematopoietic, hepatic, and renal function obtained <=4 weeks prior to
registration:

- Platelet count at least 100,000/mm^3

- White Blood Cell (WBC) count at least 4,000/mm^3 OR absolute neutrophil count at
least 2,000/mm^3

- Bilirubin normal

- Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper
limit of normal

- Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min

- Fertile patients must use 2 methods of effective contraception for 4 weeks prior to,
during, and for 4 weeks after study therapy

- Concurrent filgrastim (G-CSF) allowed for persistent neutropenia

Exclusion Criteria:

- Positive pregnancy test,pregnant or nursing

- Uncontrolled high blood pressure, unstable angina, congestive heart failure, or
myocardial infarction within the prior year

- Serious cardiac arrhythmias requiring medication

- Prior radiotherapy to only area of measurable or active tumor

- Less than 5 years since prior chemotherapy

- Other active malignancies

- Serious uncontrolled active infection

- Evidence of greater than grade 1 neuropathy by history or physical examination

- History of seizure disorders

- Contraindication to daily low-dose (81 mg/day) aspirin

Gender: Both
Steward Physician(s)
  • Joan H. Schiller, MD
Facilities
  • Morton Hospital - Terminated
Trial Interventions
Drug
  • carboplatin
  • paclitaxel
  • thalidomide
Radiation
  • radiation therapy
Physician Researcher

Investigator Name:

  • Joan H. Schiller, MD

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00004859
Volunteers:  Not Accepting Healthy Volunteers

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