Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: carboplatin; paclitaxel; thalidomide; radiation therapy
Intervention description: Induction Chemotherapy dosing: AUC=6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing, AUC=2; 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy; Induction chemotherapy dosing: 225 mg/m² (3 hour infusion) Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing: 45 mg/m2; administered weekly during radiotherapy over one hour; Induction Chemotherapy dosing: oral daily, starting Day 1 for 24 months or until disease progression. Concurrent Chemotherapy / Radiotherapy dosing: oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.; Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV
Intervention MeSH terms: Thalidomide; Paclitaxel; Carboplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 589.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      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.
    

Eligibility criteria:

        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