Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Wake Forest University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003202

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 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	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: gemcitabine hydrochloride Radiation: radiation therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	48
Study Start Date:	January 1998

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003202

Locations

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Arthur William Blackstock, MD

Comprehensive Cancer Center of Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00003202 History of Changes
Other Study ID Numbers:	CDR0000066052, CCCWFU-62197, NCI-G98-1386
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 09, 2012