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Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00003202
First received: November 1, 1999
Last updated: July 11, 2012
Last verified: July 2012

November 1, 1999
July 11, 2012
January 1998
April 2002   (final data collection date for primary outcome measure)
•Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00003202 on ClinicalTrials.gov Archive Site
assess the efficacy of dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy [ Time Frame: 72 days ]
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Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
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)

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.

OBJECTIVES:

  • 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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: cisplatin
  • Drug: gemcitabine hydrochloride
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2006
April 2002   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 1 year

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL

Renal:

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

Pulmonary:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

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

Surgery:

  • Not specified
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003202
CDR0000066052, CCCWFU-62197, NCI-G98-1386
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: Arthur William Blackstock, MD Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP