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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004093
Recruitment Status : Terminated (Original Principal Investigator left the institution.)
First Posted : November 4, 2003
Last Update Posted : June 6, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

RATIONALE: Drugs used in chemotherapy 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 chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage III non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: Gemcitabine Drug: paclitaxel Drug: vinorelbine Radiation: radiation therapy Drug: Navelbine Drug: Taxol Phase 1 Phase 2

Detailed Description:

OBJECTIVES: I. Determine the feasibility of the concurrent chemoradiotherapy regimen of paclitaxel and vinorelbine with standard chest radiotherapy in patients with locally advanced non-small cell lung cancer. II. Determine the maximum tolerated dose and dose limiting toxicities of this regimen in this patient population. III. Determine the radiologic response rate of induction chemotherapy with carboplatin and gemcitabine in this patient population. IV. Evaluate the pathologic response rate in patients undergoing resection. V. Evaluate the time to progression, overall survival, and quality of life in this patient population.

OUTLINE: This is a dose escalation study of vinorelbine. Patients receive induction chemotherapy consisting of carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. At 2 weeks following completion of induction chemotherapy, patients receive vinorelbine IV over 10 minutes followed by paclitaxel IV over 60 minutes weekly and radiotherapy daily for 5 consecutive days a week on weeks 1-6. Following initial induction chemotherapy, patients with stable or regressive disease may receive an additional 2-4 courses of carboplatin and gemcitabine at investigator's discretion. At approximately 2-6 weeks following completion of chemoradiotherapy, patients with resectable/operable disease undergo surgical resection. Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose limiting toxicity. Quality of life is assessed in all patients. Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 38-47 patients will be accrued for this study within 12-18 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Study of Induction Chemotherapy With Carboplatin and Gemcitabine, Followed by Chemoradiotherapy With Paclitaxel and Vinorelbine for Patients With Locally Advanced Non-Small Cell Lung Cancer
Study Start Date : August 1999
Actual Primary Completion Date : February 2002
Actual Study Completion Date : March 2002

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: carboplatin
    Carboplatin will be dosed at a target AUC of 5, and will be given on day 1 of each cycle
  • Drug: Gemcitabine
    Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of each 21-day cycle of induction chemo (following carboplatin on day 1).
  • Drug: paclitaxel
    Paclitaxel will be given on day 1 of each week for 6 weeks at a dose of 50 mg/m2.
  • Drug: vinorelbine
    Vinorelbine will be given on day 1 of each week for 6 weeks at a starting dose of 10 mg/m2, escalating up to 15 mg/m2 if no dose limiting toxicities are observed.
  • Radiation: radiation therapy
    Radiation will be given at a dose ranging between 45 to 66 Gy, depending on patient-specific characteristics.
  • Drug: Navelbine
    Navelbine will be administered at a dose of 10-15 mg/m2 in 100 cc NS to be administered over 10 minutes I.V. (one dose weekly during radiation therapy)
  • Drug: Taxol
    Taxol will be administered at a dose of 50 mg/m2 in 250 cc of NS or D5W over 60 minutes, following Navelbine (one dose weekly during radiation therapy)

Primary Outcome Measures :
  1. Maximum tolerated dose of the combination therapies [ Time Frame: After each cycle of therapy ]
    Toxicity will be assessed for each patient after each cycle of therapy. The maximum tolerated dose (MTD) will be the dose level prior to the dose in which greater than one-third of patients experience a dose-limiting toxicity.

  2. Determine the radiologic response rate of the combined study therapies [ Time Frame: After every 2 cycles of study therapy ]
    Patients will have a radiographic work-up (in the form of a chest CT) after every 2 cycles of therapy to assess tumor response to the study therapy.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIA or IIIB non-small cell lung cancer Pathologic staging of mediastinal lymph nodes required (N2, N3) Bidimensionally measurable disease by x-ray, CT scan, or MRI OR Evaluable disease (e.g., pulmonary infiltrate evaluable on x-ray) No malignant pleural effusions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 50 mL/min Cardiovascular: No active cardiac ischemia No congestive heart failure Other: No significant active infection No other severe complicating medical illness (e.g., severe neurologic or psychiatric disease that would prevent compliance) No concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior pelvic or thoracic radiotherapy Surgery: Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004093

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United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
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Study Chair: Gregory A. Masters, MD Robert H. Lurie Cancer Center
Publications of Results:
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Responsible Party: Northwestern University Identifier: NCT00004093    
Other Study ID Numbers: NU 99L1
First Posted: November 4, 2003    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: May 2012
Keywords provided by Northwestern University:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs