S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Pancoast Syndrome
Intervention: cisplatin; docetaxel; etoposide; conventional surgery; radiation therapy
Intervention description: During induction:50 mg/m2,IV on Days 1, 8, 29 & 36. In any appropriate vehicle over 60 minutes; During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes; During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes.; If, based upon the evaluation in Section 7.4a, there is no evidence of progression (see Section 10.2d for definition), patients will proceed to the next appropriate step: Registration #2 and surgery followed by Registration #3 and additional chemotherapy (Sections 7.5 and 7.6). Response determinations (CR,PR, SD) will be required. If criteria for progressive measurable or nonmeasurable disease (see Section 10.0) are met, the patient will then be removed from protocol treatment and receive follow-up according to the schedule. Surgery will be performed 3 - 7 weeks after completion of chemoradiotherapy.; Radiotherapy is to begin within 24 hours following the start of chemotherapy. Day 1 of radiotherapy must be a Monday, Tuesday or Wednesday, but no later in the week to insure simultaneous therapy for the majority of each chemotherapy cycle. The total dose to the prescription point will be 4,500 cGy given in 25 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter.
Intervention MeSH terms: Docetaxel; Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Healthy volunteers: No
Keywords: stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, use
      different ways to stop tumor cells from dividing so they stop growing or die. Radiation
      therapy uses high-energy x-rays to damage tumor cells. Combining cisplatin and etoposide with
      radiation therapy may shrink the tumor so it can be removed by surgery. Giving docetaxel
      after surgery may kill any remaining tumor cells.

      PURPOSE: This phase II trial is studying how well giving chemoradiotherapy together with
      cisplatin and etoposide followed by surgery and docetaxel works in treating patients with
      newly diagnosed Pancoast tumors, a type of non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer

               -  Any of the following stages due to involvement of the superior sulcus:

                    -  Stage IIB (T3, N0), IIIA (T3, N1), or IIIB (T4, N0-1)

               -  Newly diagnosed

               -  Primary bronchogenic

          -  Must meet 1 of the following tumor involvement criteria:

               -  An apical tumor associated with the Pancoast syndrome (arm or shoulder pain
                  and/or neurologic findings corresponding to the roots of C-8 and/or T-1 or the
                  inferior trunk of the bronchial plexus with or without Horner's syndrome) without
                  rib or vertebral body involvement

               -  Superior sulcus tumors with involvement of the chest wall (T3), usually ribs 1
                  and 2 by CT scan or MRI, with or without an associated Pancoast syndrome

               -  Superior sulcus tumors with invasion of the vertebral bodies or involvement of
                  the subclavian vessels (T4) by CT scan or MRI, with or without an associated
                  Pancoast syndrome

          -  No more than 1 parenchymal lesion in the same lung or in both lungs

          -  No involvement of the following lymph node groups as determined by mediastinal
             exploration* (i.e., mediastinoscopy, mediastinotomy, thoracoscopy, or thoracotomy)
             within the past 42 days:

               -  Single-level or multi-level ipsilateral or contralateral mediastinal nodal (N2 or
                  N3) disease by mediastinoscopy, thoracoscopy, mediastinotomy, thoracotomy, or
                  transbronchial Wang needle biopsy, regardless of whether enlarged nodes are
                  visible or not on chest x-ray or CT scan

               -  Supraclavicular (scalene) nodes

                    -  Any nodes evident on physical exam must be biopsied by fine needle
                       aspiration or open biopsy

               -  Left upper lobe tumors with left vocal cord paralysis by indirect laryngoscopy
                  (presumes N2 nodes in the A-P window) NOTE: *Mediastinal exploration is not
                  required for patients whose mediastinum is negative by both positron-emission
                  tomography (PET) and CT scan

          -  No pleural effusions except if 1 of the following criteria are met:

               -  Pleural effusion present before mediastinoscopy or thoracotomy with negative
                  cytology on 2 separate thoracenteses

               -  Pleural effusion present only after exploratory or staging thoracotomy, with
                  negative cytology on a single thoracentesis

               -  Present only on CT scan and too small to tap

          -  No pericardial effusions or superior vena cava syndrome

          -  No brain metastases by CT scan or MRI

          -  No evidence of distant metastatic disease by bone scan or PET

          -  Must be a candidate for potential future pulmonary resection

        PATIENT CHARACTERISTICS:

        Age

          -  Not specified

        Performance status

          -  Zubrod 0-2

               -  Patients with Zubrod performance status 2 must have an albumin level at least
                  0.85 times lower limit of normal and weight loss no greater than 10%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)*

          -  SGOT or SGPT no greater than 1.5 times ULN* NOTE: *Unless due to a documented benign
             disease

        Renal

          -  Creatinine clearance at least 50 mL/min

        Cardiovascular

          -  No myocardial infarction within the past 3 months

          -  No active angina

          -  No unstable heart rhythms

          -  No clinically evident congestive heart failure

        Pulmonary

          -  Preresection FEV_1 at least 2.0 L OR

          -  Predicted postresection FEV_1 greater than 1.0 L

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No uncontrolled peptic ulcer disease

          -  No grade 2 or greater sensory neuropathy

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent colony-stimulating factors during chemoradiotherapy or course 1 of
             consolidation therapy

        Chemotherapy

          -  No prior chemotherapy for lung cancer

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy to the neck or thorax

          -  No concurrent intensity-modulated radiotherapy

        Surgery

          -  Prior exploratory thoracotomy allowed only for diagnosis or staging purposes

        Other

          -  No concurrent amifostine