Skip to main content
OpenTrials
Completed

NCT Number: NCT00004160

Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed

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 chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have stage III non-small cell lung cancer that cannot be surgically removed.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

About this study

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of gemcitabine and paclitaxel in combination with radiotherapy in patients with locally advanced stage IIIA or IIIB non-small cell lung cancer. II. Assess response rate, duration of response, disease free survival and failure in this patient population on this regimen. III. Determine the pharmacokinetics of gemcitabine and paclitaxel during the chemoradiotherapy phase.

OUTLINE: This is a dose escalation study of gemcitabine. Induction phase: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 2 courses. Chemoradiotherapy phase: Patients receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes beginning 2 hours into paclitaxel infusion on day 1 of weeks 6, 9, and 12. Patients undergo conventional chest radiotherapy on Monday though Friday for weeks 6-11. Cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 5 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A minimum of 17 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced, unresectable non- small cell lung cancer Stage IIIA or IIIB Local, unresectable recurrence after primary surgery allowed Measurable or evaluable disease No contralateral pleural effusion(s) or noncontiguous pleural implants T4 tumors with small ipsilateral pleural effusions allowed

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No prior myocardial infarction within the past 6 months No congestive heart failure No uncontrolled arrhythmias Pulmonary: FEV1 greater than 800 mL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No history of hypersensitivity to drugs formulated in Cremophor EL No other malignancy within the past 5 years, except: Nonmelanomatous skin cancer Carcinoma in situ of the cervix No overt psychosis or other major debilitating disorder that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Treatment and study plan

Cisplatin

Drug

gemcitabine hydrochloride

Drug

paclitaxel

Drug

radiation therapy

Radiation

Primary outcomes

  1. Determine the maximum tolerated dose and dose limiting toxicity of gemcitabine and paclitaxel in combination with radiotherapy in patients with locally advanced stage IIIA or IIIB non-small cell lung cancer.

    Time frame: baseline to 6 - 11 weeks

Secondary outcomes

  1. Assess response rate, duration of response, disease free survival and failure in this patient population on this regimen.

    Time frame: baseline to 6 - 11 weeks

  2. Determine the pharmacokinetics of gemcitabine and paclitaxel during the chemoradiotherapy phase

    Time frame: baseline to 6 - 11 weeks

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Sequential and Concomitant Chemoradiotherapy With Gemcitabine-Based Chemotherapy for Inoperable Stage IIIa and IIIb Non-Small Cell Lung Cancer: A Phase I/IIa Study

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Jul 19, 2004
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.