Gemcitabine, Carboplatin or Paclitaxel Plus Radiation Therapy in Treating Patients With Stage IIIA or IIIB Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00016315
First received: May 6, 2001
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, 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. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients With Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • To determine the maximum tolerated dose of gemcitabine with carboplatin-based chemotherapy and radiation therapy [ Time Frame: From start of treatment to 90 days ] [ Designated as safety issue: Yes ]
  • To determine the maximum tolerated dose of gemcitabine with paclitaxel-based chemotherapy and radiation therapy [ Time Frame: From start of treatment to 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: May 2001
Study Completion Date: June 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Sequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT)
Drug: gemcitabine hydrochloride Radiation: radiation therapy
Experimental: Arm 2
Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT
Drug: gemcitabine hydrochloride Drug: paclitaxel Radiation: radiation therapy
Experimental: Arm 3
Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT
Drug: carboplatin Drug: gemcitabine hydrochloride Radiation: radiation therapy
Experimental: Arm 4
Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT
Drug: gemcitabine hydrochloride Drug: paclitaxel Radiation: radiation therapy
Experimental: Arm 6
Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT
Drug: gemcitabine hydrochloride Drug: paclitaxel Radiation: radiation therapy
Experimental: Arm 8
Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT
Drug: gemcitabine hydrochloride Drug: paclitaxel Radiation: radiation therapy
Experimental: Arm 10
Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Drug: gemcitabine hydrochloride Drug: paclitaxel Radiation: radiation therapy
Experimental: Arm 12
Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Drug: gemcitabine hydrochloride Drug: paclitaxel Radiation: radiation therapy
Experimental: Arm 14
Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Drug: gemcitabine hydrochloride Drug: paclitaxel Radiation: radiation therapy
Experimental: Arm 5
Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT
Drug: carboplatin Drug: gemcitabine hydrochloride Radiation: radiation therapy
Experimental: Arm 7
Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT
Drug: carboplatin Drug: gemcitabine hydrochloride Radiation: radiation therapy
Experimental: Arm 9
Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT
Drug: carboplatin Drug: gemcitabine hydrochloride Radiation: radiation therapy
Experimental: Arm 11
Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT
Drug: carboplatin Drug: gemcitabine hydrochloride Radiation: radiation therapy

Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) of gemcitabine when administered with carboplatin and thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in patients with stage IIIA or IIIB non-small cell lung cancer.
  • Determine the MTD of gemcitabine and paclitaxel when administered with thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in these patients.

OUTLINE: This is a multicenter, dose-escalation study of gemcitabine and paclitaxel. Patients are sequentially assigned to 1 of 3 treatment regimens.

  • Regimen A: Patients receive gemcitabine IV over 30-60 minutes on days 1, 8, 22, 29, and 43 and thoracic radiotherapy daily 5 days a week for 7 weeks beginning on day 1.
  • Regimen B (closed to accrual as of 5/13/03): Patients receive gemcitabine and thoracic radiotherapy as in regimen A and carboplatin IV over 30 minutes on days 1, 8, 22, 29, and 43.
  • Regimen C: Patients receive gemcitabine and thoracic radiotherapy as in regimen A and paclitaxel IV over 1 hour on days 1, 8, 22, 29, and 43.

At 3 weeks after completion of chemoradiotherapy, all patients receive adjuvant gemcitabine IV over 30-60 minutes on days 71, 78, 92, and 99 and carboplatin IV over 30 minutes on days 71 and 92.

The first 6 patients enrolled receive regimen A to determine the safety of the initial dose of gemcitabine. After completion of regimen A, cohorts of 3-6 patients receive escalating doses of gemcitabine in regimen B (closed to accrual as of 5/13/03) until the maximum tolerated dose (MTD) is determined. In a separate sequence, cohorts of 3-6 patients receive alternating escalating doses of gemcitabine and paclitaxel in regimen C until the MTD is determined. The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity.

Patients are followed at 3 months, 6 months, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 29 months.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed loco-regionally advanced non-small cell lung cancer meeting one of the following staging criteria:

    • Medically inoperable stage IIIA
    • Unresectable stage IIIA or IIIB
  • Measurable disease on three-dimensional planning CT scan
  • No post-resection intrathoracic tumor recurrence
  • No pleural effusion on chest x-ray except those occurring after attempted thoracotomy or other invasive thoracic procedure
  • No evidence of small cell histology
  • No evidence of hematogenous or distant metastases

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count at least 100,000/mm^3
  • Absolute granulocyte count at least 2,000/mm^3
  • Hemoglobin at least 8.0 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • Serum glutamate oxaloacetate transaminase (SGOT) no greater than 1.5 times upper limit of normal (unless caused by documented benign disease)

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No myocardial infarction within the past 6 months
  • No symptomatic heart disease, including angina, congestive heart failure, or uncontrolled arrhythmia

Pulmonary:

  • Forced expiratory volume (FEV)_1 greater than 1,000 mL

Other:

  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
  • No weight loss of more than 10% in 3 months prior to diagnosis
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior thoracic or neck radiotherapy

Surgery:

  • See Disease Characteristics
  • No prior complete or subtotal tumor resection
  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: NCT00016315

Locations
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Iowa
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States, 52001
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
Cancer Care Center, Incorporated
Salem, Ohio, United States, 44460
United States, Pennsylvania
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Dale and Frances Hughes Cancer Center
East Stroudsburg, Pennsylvania, United States, 18301
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
United States, Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-5671
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, Wisconsin
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Hak Choy, MD Simmons Cancer Center
  More Information

Additional Information:
Publications:
Choy H, Swann S, Curran W, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG 0017 study. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-70, S42, 2005.
Choy H, Swann S, Walter C, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG study. [Abstract] J Clin Oncol 23 (Suppl 16): A-7103, 646s, 2005.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00016315     History of Changes
Other Study ID Numbers: RTOG-0017, RTOG-L-0017, CDR0000068622
Study First Received: May 6, 2001
Last Updated: October 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

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

ClinicalTrials.gov processed this record on September 18, 2014