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

This study has been terminated.
(Original Principal Investigator left the institution.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00004093
First received: December 10, 1999
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: Gemcitabine
Drug: paclitaxel
Drug: vinorelbine
Radiation: radiation therapy
Drug: Navelbine
Drug: Taxol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Maximum tolerated dose of the combination therapies [ Time Frame: After each cycle of therapy ] [ Designated as safety issue: Yes ]
    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.

  • Determine the radiologic response rate of the combined study therapies [ Time Frame: After every 2 cycles of study therapy ] [ Designated as safety issue: No ]
    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.


Enrollment: 36
Study Start Date: August 1999
Study Completion Date: March 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004093

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Gregory A. Masters, MD Robert H. Lurie Cancer Center
  More Information

Publications:
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00004093     History of Changes
Other Study ID Numbers: NU 99L1, NU-99L1, NCI-G99-1585
Study First Received: December 10, 1999
Last Updated: May 31, 2012
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Gemcitabine
Paclitaxel
Vinorelbine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014