Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Lung Cancer

In brief

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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. Giving paclitaxel and carboplatin together with radiation therapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any tumor cells remaining after surgery. PURPOSE: This phase II trial is studying how well giving paclitaxel and carboplatin together with radiation therapy works in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

Key facts

Study ID

NCT00096226

Run by

Radiation Therapy Oncology Group

People needed

60

Starts

2004-09-01

Expected to finish

2016-05-16

Last updated by the study team

2019-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Stage IIIA (T1-3 N2) or Stage IIIB (N3, excluding supraclavicular involvement) non-small cell lung cancer documented by biopsy or cytology (Pancoast tumors are eligible if pathologic evidence of mediastinal nodal disease is present);
• Disease must be measurable;
• Mediastinal lymph nodes must be proven positive by pathologic review. All patients must undergo mediastinoscopy, thoracoscopy, Chamberlain procedure, or transbronchial needle aspirate to evaluate extent of nodal involvement. Any lymph node assessed by mediastinoscopy and found to be positive will be defined as N2 disease;
• Patients ≥ 18 years of age;
• Life expectancy ≥ 6 months;
• Zubrod performance status 0- 1 (See Appendix II);
• Pretreatment laboratory values must be as follows: White blood cell count (WBC) count: ≥ 3,000/mm\^3; Absolute granulocyte count: ≥ 1,500/mm\^3; Platelets: ≥ 100,000/mm3; Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN); Serum creatinine: ≤ 1.5 x institutional ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x institutional ULN; serum albumin: ≥ 3.0 g/dL
• Baseline forced expiratory volume (FEV1) must be at least 2.0 liters; if less than 2.0 then V/Q scan is required and projected post-operative FEV1 must be > 800 cc based on the following formula using the quantitative Ventilation/perfusion (V/Q) scan: FEV1 = FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report.
• Patient evaluation and acceptance by thoracic surgery, medical oncology, and radiation oncology; patient must be a potential surgical candidate prior to the initiation of therapy;
• Women of childbearing potential and male participants must practice an effective method of contraception during the study;
• Pretreatment evaluations required for eligibility include:
• A complete medical history \& physical examination to include Zubrod performance status, neurologic assessment, recent weight loss, usual weight, concurrent non-malignant disease and therapy;
• Location, type, and size of measurable lesion must be recorded prior to treatment;
• Complete blood count (CBC) with differential, platelet count, electrolytes, and Mg++ within 14 days prior to study entry;
• Twelve-channel serum multiple analysis (SMA-12): Total protein, Albumin, Calcium, Glucose, Blood urea nitrogen (BUN), Creatinine, Alkaline Phosphatase, Lactate dehydrogenase (LDH), Total Bilirubin, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) within 14 days prior to study entry;
• Women of childbearing potential must have a negative pre-study serum or urine pregnancy test within 14 days prior to study entry.
• Mediastinoscopy, thoracoscopy, Chamberlain procedure, or bronchoscopy with transbronchial needle aspirate to evaluate the extent of lymph node involvement;
• Computed tomography (CT) scan of the chest to include liver, and adrenal glands within 6 weeks prior to study entry;
• Positron emission tomography (PET) scan within 8 weeks prior to study entry. Any suspicious areas outside of the local regional disease requires documented evaluation of these findings to exclude metastatic disease;
• CT scan or magnetic resonance imaging (MRI) of the brain within 6 weeks prior to study entry;
• Electrocardiogram (EKG) and pulmonary function tests including forced vital capacity (FVC), FEV-1, and diffusing capacity of carbon monoxide (DLCO), within 8 weeks prior to study entry; V/Q scan, if applicable, within 8 weeks prior to study entry.
• Patients must sign a study-specific informed consent prior to study entry.

You may not qualify if…

• Small cell lung cancer; distant metastatic disease;
• Evidence of clinical or radiographic supraclavicular lymph node involvement;
• Bronchioalveolar carcinoma with lobar or multilobar involvement;
• Unintentional weight loss > 5% within 6 months prior to study entry, or Zubrod performance status 2 or greater;
• Primary tumor location prevents delivery of 60 Gy and simultaneously limiting spinal cord dose to 48 Gy;
• Patients with malignant pleural effusion;
• Clinically evident superior vena cava syndrome;
• Prior systemic chemotherapy or radiation therapy to the thorax;
• Patients with known hypersensitivity to Cremophor EL;
• Patients receiving other investigational therapy;
• Pregnant or lactating women are ineligible, as treatment involves unforeseeable risks to the participant and to the embryo or fetus;
• Patients with an active serious infection or other serious underlying medical condition that would impair their ability to complete protocol treatment;
• Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.

Where it is running

• Arizona Oncology Services Foundation — Phoenix, Arizona, United States
• Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea — Scottsdale, Arizona, United States
• USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• Cancer Institute at St. John's Hospital — Springfield, Illinois, United States
• Greenebaum Cancer Center at University of Maryland Medical Center — Baltimore, Maryland, United States
• Saint Joseph Mercy Cancer Center — Ann Arbor, Michigan, United States
• CCOP - Michigan Cancer Research Consortium — Ann Arbor, Michigan, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis — St Louis, Missouri, United States
• Methodist Estabrook Cancer Center — Omaha, Nebraska, United States
• Cancer Institute of New Jersey at Cooper University Hospital - Camden — Camden, New Jersey, United States
• Cancer Institute of New Jersey at Cooper - Voorhees — Voorhees Township, New Jersey, United States
• Leo W. Jenkins Cancer Center at ECU Medical School — Greenville, North Carolina, United States
• St. Luke's Cancer Network at St. Luke's Hospital — Bethlehem, Pennsylvania, United States
• Hollings Cancer Center at Medical University of South Carolina — Charleston, South Carolina, United States
• Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center — Kingsport, Tennessee, United States
• Schiffler Cancer Center at Wheeling Hospital — Wheeling, West Virginia, United States
• St. Vincent Hospital Regional Cancer Center — Green Bay, Wisconsin, United States
• Medical College of Wisconsin Cancer Center — Milwaukee, Wisconsin, United States
• Veterans Affairs Medical Center - Milwaukee — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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