S0429: Docetaxel, Cetuximab, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: cetuximab; docetaxel; radiation therapy
Intervention description: Cohorts 1 and 2: 400 mg/m2 (initial dose) 2 hour IV infusion on Day 1, Cycle 1 only.
250 mg/m2, 1 hour IV infusion on Days 8 , 15 and 22 during Cycle 1. 250 mg/m2 (subsequent doses), 1 hour IV infusion on Days 1, 8 , 15 and 22 during subsequent cycles.; Cohort 2 ONLY: 20 mg/m2 IV over 15 - 30 minutes on Days 8, 15 and 22 of Cycle 1. Concurrent with RT and cetuximab starting at Week 2.
20 mg/m2 IV over 15 - 30 minutes on Days 1, 8, 15 and 22 of Cycle 2.; Radiation therapy should begin on Day 8 of Cycle 1 and continue through the end of Cycle 2. Refer to Section 12.1 for Radiation Therapy Review.
RT prescription should be PTV (GTV + 2-cm margins on CT scan) to 6,480 cGy in 36 fractions given 5 days a week, 180 cGy per day. The dose is prescribed to the isocenter. The entire treatment should be planned prior to starting treatment to ensure that the plan meets protocol specifications.
Intervention MeSH terms: Docetaxel; Cetuximab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; adenocarcinoma of the lung; large cell lung cancer; squamous cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find
      tumor cells and kill them or carry tumor-killing substances to them. Others interfere with
      the ability of tumor cells to grow and spread. Radiation therapy uses high-energy x-rays to
      kill tumor cells. Giving docetaxel and cetuximab together with radiation therapy may kill
      more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when
      given together with cetuximab and radiation therapy in treating patients with stage III
      non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically proven newly diagnosed single, primary, bronchogenic
             stage IIIA or selected stage IIIB (excluding malignant pleural effusion) non-small
             cell lung cancer (NSCLC) of one of the following cellular types:

               -  Adenocarcinoma

               -  Large cell carcinoma

               -  Squamous cell carcinoma

               -  Unspecified

          -  Histology or cytology from involved mediastinal or supraclavicular nodes will be
             sufficient for diagnosis if a separate primary lesion of the lung parenchyma is
             clearly evident on radiographs (i.e., a second biopsy will not be required)

          -  Underwent positron emission tomography (PET) scan within the past 42 days

               -  N2 or N3 mediastinal disease by PET scan OR enlarged nodes on CT scan determined
                  to be N2 or N3 by biopsy

          -  Measurable disease, defined as lesions that can be accurately measured in at least one
             dimension as ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan

               -  Pleural effusion, ascites, bone lesions, and laboratory parameters are not
                  considered measurable disease

          -  No brain metastases

          -  Malignant pleural effusion allowed provided 1 of the following is true:

               -  Present before mediastinoscopy or exploratory thoracotomy AND the pleural fluid
                  is transudate with negative cytology

               -  Present only after but not before exploratory or staging thoracotomy AND the
                  pleural fluid is either transudate or exudate with negative cytology

               -  Present only on CT scan but not on decubitus chest x-ray AND deemed too small to
                  tap under either CT scan or ultrasound guidance

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1, meeting ≥ 1 of the following criteria OR Zubrod
             performance status 2 with no co-morbidities or meeting 1 of the following criteria:

               -  No co-morbidities

               -  FEV_1 < 2 L OR < 1 L with estimated contralateral FEV_1 ≥ 0.6 L

               -  DLCO > 10 mL/mm Hg/min

               -  Albumin < 0.85 times lower limit of normal

               -  Unintentional weight loss > 10% within the past 6 months

               -  Controlled congestive heart failure which, in the opinion of the investigator,
                  may become decompensated due to radiotherapy

          -  FEV_1 < 2 L OR < 1 L with estimated contralateral FEV_1 ≥ 0.6 L

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Must provide prior smoking history

          -  Serum bilirubin normal

          -  Meets one of the following criteria:

               -  Alkaline phosphatase (AP) ≤ 4 times ULN AND SGOT or SGPT normal

               -  AP normal AND SGOT or SGPT ≤ 2.5 times ULN

          -  No other prior malignancy within the past 5 years except adequately treated basal cell
             or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I
             or II cancer from which the patient is currently in complete remission

          -  No pregnant or nursing patients

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or curative surgery for this cancer

          -  No prior radiotherapy to the neck and/or thorax for any reason

          -  No prior therapy which specifically targets the EGFR pathway

          -  No concurrent growth factors (e.g., filgrastim [G-CSF], epoetin alfa, or
             pegfilgrastim) or amifostine

          -  No concurrent intensity-modulated radiotherapy

          -  No concurrent prophylactic mediastinal, contralateral hilar, or supraclavicular lymph
             node radiotherapy