Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

NCT ID: NCT00088556

Last Updated: 2012-05-31

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2009-05-31

Brief Summary

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The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

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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Triplet Combination of TLK286 Carboplatin & Paclitaxel

Experimental

Group Type EXPERIMENTAL

TLK286

Intervention Type DRUG

Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²

carboplatin

Intervention Type DRUG

AUC 6 mg/mL/min Once every 3 weeks

paclitaxel

Intervention Type DRUG

200 mg/m² Once every 3 weeks

Interventions

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TLK286

Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²

Intervention Type DRUG

carboplatin

AUC 6 mg/mL/min Once every 3 weeks

Intervention Type DRUG

paclitaxel

200 mg/m² Once every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Histologically confirmed non-small cell lung cancer (NSCLC)
* Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)
* Measurable disease by RECIST
* ECOG status of 0-1
* Adequate liver and renal function
* Adequate bone marrow reserves

Exclusion Criteria

* Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC
* Up to one prior adjuvant or neoadjuvant chemotherapy is allowed
* History of bone marrow transplantation or stem cell support
* Pregnant or lactating women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Telik

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bay Area Cancer Research Group

Concord, California, United States

Site Status

East Bay Medical Oncology/Hematology Associates

Concord, California, United States

Site Status

Southwest Cancer Care

Escondido, California, United States

Site Status

Kaiser Permanente Medical Center

Hayward, California, United States

Site Status

Southwest Cancer Care

Murrieta, California, United States

Site Status

Kaiser Permanente Medical Center

Oakland, California, United States

Site Status

Southwest Cancer Care

Poway, California, United States

Site Status

Kaiser Permanente Medical Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center

San Francisco, California, United States

Site Status

Kaiser Permanente Medical Center

San Jose, California, United States

Site Status

Kaiser Permanente Medical Center

Santa Clara, California, United States

Site Status

Kaiser Permanente Medical Center

So. San Francisco, California, United States

Site Status

Kaiser Permanente Medical Center

Vallejo, California, United States

Site Status

Diablo Valley Oncology & Hematology Medical Group

Walnut Creek, California, United States

Site Status

Kaiser Permanente Medical Center

Walnut Creek, California, United States

Site Status

Citrus Hematology and Oncology

Crystal River, Florida, United States

Site Status

Citrus Hematology and Oncology Center

Inverness, Florida, United States

Site Status

Florida Wellcare Alliance, LC

Inverness, Florida, United States

Site Status

Kansas City Cancer Center

Kansas City, Kansas, United States

Site Status

Kansas City Cancer Center - Central Research Dept. Data Office & Drug Discovery Location

Lenexa, Kansas, United States

Site Status

Kansas City Cancer Center

Overland Park, Kansas, United States

Site Status

Department of Veterns Affairs - Overton Brooks VA Medical Center

Shreveport, Louisiana, United States

Site Status

LSU Health Sciences Center

Shreveport, Louisiana, United States

Site Status

University of Maryland, Baltimore University of Maryland Medical System-Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status

Center for Cancer and Blood Disorders, P. C.

Bethesda, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Kansas City Cancer Center

Kansas City, Missouri, United States

Site Status

Kansas City Cancer Center

Kansas City, Missouri, United States

Site Status

Kansas City Cancer Center

Kansas City, Missouri, United States

Site Status

Kansas City Cancer Center

Lee's Summit, Missouri, United States

Site Status

St. John's Mercy Medical Center

St Louis, Missouri, United States

Site Status

St. John's Mercy Hospital

Washington, Missouri, United States

Site Status

Clinical Research Service

Scottsbluff, Nebraska, United States

Site Status

Horizons West Medical Group

Scottsbluff, Nebraska, United States

Site Status

Dakota Cancer Institute

Fargo, North Dakota, United States

Site Status

Odyssey Research

Fargo, North Dakota, United States

Site Status

Tennessee Oncology, PLLC

Clarksville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Franklin, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Hermitage, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Lebanon, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Murfreesboro, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Smyrna, Tennessee, United States

Site Status

Texas Cancer Associates

Dallas, Texas, United States

Site Status

Texas Cancer Associates

Plano, Texas, United States

Site Status

Danville Hematology & Oncology, Inc.

Danville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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TLK286.2023

Identifier Type: -

Identifier Source: org_study_id

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