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

NCT ID: NCT00004160

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Study Completion Date

2004-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Keywords

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stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose 1 Gemcitabine

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.

Group Type EXPERIMENTAL

cisplatin

Intervention Type DRUG

gemcitabine hydrochloride

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Dose 2 Gemcitabine

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.

Group Type EXPERIMENTAL

cisplatin

Intervention Type DRUG

gemcitabine hydrochloride

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Dose 3 Gemcitabine

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.

Group Type EXPERIMENTAL

cisplatin

Intervention Type DRUG

gemcitabine hydrochloride

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Dose 4 Gemcitabine

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.

Group Type EXPERIMENTAL

cisplatin

Intervention Type DRUG

gemcitabine hydrochloride

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Dose 5 Gemcitabine

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.

Group Type EXPERIMENTAL

cisplatin

Intervention Type DRUG

gemcitabine hydrochloride

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Interventions

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cisplatin

Intervention Type DRUG

gemcitabine hydrochloride

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francisco Robert, MD, FACP

Role: STUDY_CHAIR

University of Alabama at Birmingham

Locations

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University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Divers SG, Spencer SA, Carey D, Busby EM, Hyatt MD, Robert F. Phase I/IIa study of cisplatin and gemcitabine as induction chemotherapy followed by concurrent chemoradiotherapy with gemcitabine and paclitaxel for locally advanced non-small-cell lung cancer. J Clin Oncol. 2005 Sep 20;23(27):6664-73. doi: 10.1200/JCO.2005.02.519.

Reference Type RESULT
PMID: 16170174 (View on PubMed)

Other Identifiers

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UAB-9718

Identifier Type: -

Identifier Source: secondary_id

UAB-F97073005

Identifier Type: -

Identifier Source: secondary_id

NCI-G99-1625

Identifier Type: -

Identifier Source: secondary_id

CDR0000067400

Identifier Type: -

Identifier Source: org_study_id