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Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With 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: NCT00003202
Recruitment Status : Completed
First Posted : November 26, 2003
Last Update Posted : August 10, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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 radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to compare the effectiveness of gemcitabine with radiation therapy alone or following two-drug combination chemotherapy in treating patients with stage III non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: gemcitabine hydrochloride Radiation: radiation therapy Phase 1 Phase 2

Detailed Description:


  • Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy alone or following 2 cycles of induction chemotherapy in patients with Stage IIIA or IIIB non-small cell lung cancer.
  • Assess the toxicity of concurrent thoracic radiation and gemcitabine in these patients.
  • Determine the effectiveness of concurrent radiation and gemcitabine by determining the complete response rate, partial response rate, time to recurrence, pattern of recurrence, and overall survival in a cohort of these patients.

OUTLINE: This is an alternating two arm, dose escalation, multicenter study.

Arm I: Patients receive twice-weekly gemcitabine as a 30 minute infusion. Concurrent radiation therapy is administered 5 days a week for 6 weeks.

Arm II: Patients receive 2 cycles of induction chemotherapy consisting of gemcitabine as a 30 minute infusion on day 1 and 8 and cisplatin IV over 1 hour on day 1. Each cycle is 21 days. Patients then receive gemcitabine and radiation therapy as in arm I.

Cohorts of 3 patients are enrolled into each treatment arm at each dose level of gemcitabine. Toxicity for each arm is assessed independently. Once dose limiting toxicity (DLT) is observed at any dose level, 3 more patients are enrolled at the same dose level. The maximum tolerated dose (MTD) is defined as the dose at which no more than 1 of 6 patients experiences grade 4 toxicity, or no more than 4 of 6 patients experience grade 3 or worse toxicity (DLT). After the MTD is determined for each treatment arm, additional patients are treated at that dose level for the phase II portion of the study.

Patients are followed every 3 months for 2 years, then every 4 months for the next 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: There will be approximately 24-48 patients accrued into this study within 1-2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alternating Phase I/II Trials of Twice-Weekly Infusion Gemcitabine (2'2'-Difluoro-2'-Deoxycytidine) and Concurrent Thoracic Radiation Alone - Or Following 2 Cycles of Cisplatin/Gemcitabine Induction Chemotherapy for the Treatment of Stage IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)
Study Start Date : January 1998
Actual Primary Completion Date : April 2002
Actual Study Completion Date : July 2006

Primary Outcome Measures :
  1. •Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. assess the efficacy of dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy [ Time Frame: 72 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed stage IIIA or IIIB non-small cell lung cancer that is unicentric and inoperable, including the following cellular types:

    • Squamous cell carcinoma
    • Adenocarcinoma
    • Bronchoalveolar carcinoma
    • Large cell anaplastic carcinoma
    • Non-small cell lung cancer not otherwise specified
  • Tumors may be multifocal if all of disease is believed to be result of direct spread
  • Disease must be fully accessible by radiotherapy ports for the entire prescribed dose
  • No supraclavicular nodes or diffuse pleural involvement
  • No contralateral hilar disease or an exudative, bloody, or cytologically malignant effusion
  • Measurable disease required for phase II of this study



  • Any age

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 1 year


  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin greater than 10 g/dL


  • Bilirubin no greater than 2.0 mg/dL


  • BUN no greater than 1.5 times normal
  • Creatinine no greater than 1.5 times normal


  • FEV1 no greater than 1 liter except if tumor has negatively impacted
  • pulmonary function


  • No other serious medical or psychiatric illness
  • No prior lung cancer except if free of disease for more than 3 years
  • No other prior malignancy except nonmelanoma skin cancer or if free of
  • disease for more than 1 year
  • Not pregnant or nursing
  • Negative pregnancy test


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • No prior thoracic radiotherapy
  • Concurrent radiotherapy to other anatomic sites allowed


  • 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): NCT00003202

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United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Study Chair: Arthur William Blackstock, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences Identifier: NCT00003202     History of Changes
Other Study ID Numbers: CDR0000066052
First Posted: November 26, 2003    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Wake Forest University Health Sciences:
squamous cell lung cancer
large cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
adenocarcinoma of the lung
adenosquamous 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
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs