Induction Gemcitabine & Carboplatin Followed by Paclitaxel & Carboplatin +XRT in NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Gemcitabine; Carboplatin; Paclitaxel; Radiation
Intervention description: Induction Chemotherapy.; Induction Chemotherapy. Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.; Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.; Radiation Therapy will begin on day 57 if there has been adequate hematologic recovery from Induction Chemotherapy.
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-small cell lung cancer; carcinoma; unresectable; Stage IIIA; Stage IIIB; thoracic radiation

Summary:

      This is a single institution Phase II study for patients with unresectable Stage IIIA and
      IIIB non-small cell lung cancer. The treatment started with 2 cycles of gemcitabine and
      carboplatin followed by concurrent chemotherapy with radiation. The chemoradiation included
      using paclitaxel and carboplatin with daily thoracic radiation to a total dose of 74 Gy.
      Response rate was determined following the chemotherapy with gemcitabine and carboplatin and
      evaluated again after the chemoradiation. Treatment toxicities were also assessed.
    

Eligibility criteria:

        Eligibility Criteria:

          -  Histologically confirmed unresectable non-small cell carcinoma of the lung
             (adenocarcinoma, squamous cell carcinoma or anaplastic large cell carcinoma). See
             below for TNM eligibility. Mediastinoscopy or thoracoscopy in patients with
             mediastinal lymph node enlargement of < 2 cm on CT scans of suspicious on PET scan to
             confirm suspected involvement. These staging procedures are not mandatory for patients
             with obvious nodal involvement (2.0 cm or greater). Staging system: The New
             International Staging System for lung cancer (Clifton F. Mountain, 1997) will be
             followed. The following stages will be eligible:

          -  Patients with stage IIIa disease will be eligible if it is felt that they are not
             candidates for possible resection following neo-adjuvant therapy (unresectable T3N1 or
             T1-3 primary tumors with metastasis limited to single station ipsilateral mediastinal
             lymph nodes). Patients with stage IIIb disease without significant* pleural effusion
             will be eligible. This includes patients with metastases to contralateral mediastinal
             or supraclavicular nodes.

          -  Patients without significant pleural effusion will constitute those in whom 1) it is
             seen on CT scan only or 2) does not reaccumulate after one thoracentesis and is
             cytologically negative.

          -  No evidence of distant metastasis.

          -  Patients must have measurable disease by the Recist Evaluation Criteria in Solid
             Tumors (RECIST) criteria. Baseline measurements/evaluations must be obtained within 4
             weeks prior to registration.

          -  Patients must not have small cell carcinoma as part of the histological specimen
             (World Health Organization [WHO] classification 22.40)

          -  Performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1 at time of
             registration.

          -  Patients with preexisting clinically significant peripheral neuropathy are ineligible.

          -  Weight loss of ≤ 5% in the preceding three months

          -  No prior systemic chemotherapy or thoracic radiotherapy.

          -  Patients must have adequate bone marrow reserve as determined by the following
             laboratory values: Obtained within 14 days prior to registration.

          -  White blood cell count 4000/ul or greater and granulocyte count of 1500/ul or greater

          -  Platelet count of 100,000/ul or greater

          -  Hemoglobin of 10 gms/dl or greater.

          -  Adequate renal and liver function as determined by the following laboratory values:
             Obtained within 14 days prior to registration.

          -  Serum creatinine < 1.5 mg/dl or creatinine clearance greater than 50 cc/min

          -  Bilirubin less than 1.5 mg/dl

          -  SGOT less than 1.5 times normal

          -  No history of a prior or concomitant malignancy in the past five years except for
             surgically cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.

          -  No concomitant life threatening or uncontrolled serious medical illness such as
             cardiac arrhythmia, end stage congestive heart failure, liver disease with significant
             hepatic insufficiency, organic brain syndrome.

          -  Women of childbearing potential and sexually active males are strongly advised to use
             an accepted and effective method of contraception.

          -  Age greater than or equal to 18 years

          -  Written, informed consent must be obtained prior to registration.