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| Sponsors and Collaborators: |
Wake Forest University 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: | 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) |
| Estimated Enrollment: | 48 |
| Study Start Date: | January 1998 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IIIA or IIIB non-small cell lung cancer that is unicentric and inoperable, including the following cellular types:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Study Chair: | Arthur William Blackstock, MD | Wake Forest University |
More Information
| Study ID Numbers: | CDR0000066052, CCCWFU-62197, NCI-G98-1386 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003202 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Antimetabolites Thoracic Neoplasms Immunologic Factors Immunosuppressive Agents Antiviral Agents Carcinoma Respiratory Tract Diseases Cisplatin Radiation-Sensitizing Agents |
Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Cisplatin Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses |
Gemcitabine Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
