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Docetaxel Plus Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

NCT ID: NCT00003562

Last Updated: 2013-12-04

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Detailed Description

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OBJECTIVES: I. Determine the effectiveness of low dose docetaxel and carboplatin by response rate, response duration, and time to progression in patients with stage IIIB or IV non-small cell lung cancer. II. Determine the side effects and toxicity profile of docetaxel when given in combination with carboplatin in these patients.

OUTLINE: This is open label study. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 30 minutes once a week for 4 weeks. Patients receive at least 2 courses (8 weeks) of treatment. Courses are further repeated in the absence of unacceptable toxicity and disease progression.

PROJECTED ACCRUAL: There will be 20-38 patients accrued into this study.

Conditions

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Lung Cancer

Keywords

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squamous cell lung cancer large cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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carboplatin

Intervention Type DRUG

docetaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB with metastatic pleural effusion or metastatic stage IV non-small cell lung cancer Large cell Adenocarcinoma Squamous cell Bronchioalveolar carcinoma Undifferentiated No small cell or carcinoid histologies At least 1 bidimensionally measurable or evaluable indicator lesion Measurable or evaluable indicator lesion(s) must be completely outside the radiation portal or there must be proof of disease progression No current CNS metastases at study entry No meningeal carcinomatosis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase less than ULN, OR alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT less than ULN Renal: Creatinine clearance at least 50 mL/min Other: No concurrent illness that would effect assessment of this study Not pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy for non-small cell lung cancer allowed Radiotherapy for new brain metastases (other than leptomeningeal disease) is allowed during study, but chemotherapy is stopped during and for 2 weeks following radiotherapy Concurrent radiotherapy to other sites allowed if there is no objective criteria for disease progression Surgery: Not specified Other: No other concurrent experimental drug
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hope Cancer Institute, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Raj Sadasivan, MD, PhD

Role: STUDY_CHAIR

Hope Cancer Institute, Inc.

Locations

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Bethany Medical Center

Kansas City, Kansas, United States

Site Status

Heartland Cancer Research Network

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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HCRN-007

Identifier Type: -

Identifier Source: secondary_id

NCI-V98-1469

Identifier Type: -

Identifier Source: secondary_id

CDR0000066626

Identifier Type: -

Identifier Source: org_study_id