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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TLK286
carboplatin
paclitaxel
Sponsored by
Telik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bay Area Cancer Research Group
  • East Bay Medical Oncology/Hematology Associates
  • Southwest Cancer Care
  • Kaiser Permanente Medical Center
  • Southwest Cancer Care
  • Kaiser Permanente Medical Center
  • Southwest Cancer Care
  • Kaiser Permanente Medical Center
  • Kaiser Permanente Medical Center
  • Kaiser Permanente Medical Center
  • Kaiser Permanente Medical Center
  • Kaiser Permanente Medical Center
  • Kaiser Permanente Medical Center
  • Diablo Valley Oncology & Hematology Medical Group
  • Kaiser Permanente Medical Center
  • Citrus Hematology and Oncology
  • Citrus Hematology and Oncology Center
  • Florida Wellcare Alliance, LC
  • Kansas City Cancer Center
  • Kansas City Cancer Center - Central Research Dept. Data Office & Drug Discovery Location
  • Kansas City Cancer Center
  • Department of Veterns Affairs - Overton Brooks VA Medical Center
  • LSU Health Sciences Center
  • University of Maryland, Baltimore University of Maryland Medical System-Greenebaum Cancer Center
  • Center for Cancer and Blood Disorders, P. C.
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Brigham & Women's Hospital
  • Dana-Farber Cancer Institute
  • Kansas City Cancer Center
  • Kansas City Cancer Center
  • Kansas City Cancer Center
  • Kansas City Cancer Center
  • St. John's Mercy Medical Center
  • St. John's Mercy Hospital
  • Clinical Research Service
  • Horizons West Medical Group
  • Dakota Cancer Institute
  • Odyssey Research
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Texas Cancer Associates
  • Texas Cancer Associates
  • Danville Hematology & Oncology, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triplet Combination of TLK286 Carboplatin & Paclitaxel

Arm Description

Experimental

Outcomes

Primary Outcome Measures

Study Objectives
To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin

Secondary Outcome Measures

Full Information

First Posted
July 29, 2004
Last Updated
May 30, 2012
Sponsor
Telik
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1. Study Identification

Unique Protocol Identification Number
NCT00088556
Brief Title
Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
Official Title
Phase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telik

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triplet Combination of TLK286 Carboplatin & Paclitaxel
Arm Type
Experimental
Arm Description
Experimental
Intervention Type
Drug
Intervention Name(s)
TLK286
Intervention Description
Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC 6 mg/mL/min Once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
200 mg/m² Once every 3 weeks
Primary Outcome Measure Information:
Title
Study Objectives
Description
To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
Time Frame
Every 6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bay Area Cancer Research Group
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
East Bay Medical Oncology/Hematology Associates
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Southwest Cancer Care
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
Southwest Cancer Care
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Southwest Cancer Care
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
So. San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Diablo Valley Oncology & Hematology Medical Group
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Citrus Hematology and Oncology
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Citrus Hematology and Oncology Center
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Florida Wellcare Alliance, LC
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Kansas City Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66112
Country
United States
Facility Name
Kansas City Cancer Center - Central Research Dept. Data Office & Drug Discovery Location
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Kansas City Cancer Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Department of Veterns Affairs - Overton Brooks VA Medical Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
University of Maryland, Baltimore University of Maryland Medical System-Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Center for Cancer and Blood Disorders, P. C.
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Kansas City Cancer Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Kansas City Cancer Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Kansas City Cancer Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Kansas City Cancer Center
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
St. John's Mercy Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
St. John's Mercy Hospital
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Clinical Research Service
City
Scottsbluff
State/Province
Nebraska
ZIP/Postal Code
69361
Country
United States
Facility Name
Horizons West Medical Group
City
Scottsbluff
State/Province
Nebraska
ZIP/Postal Code
69361
Country
United States
Facility Name
Dakota Cancer Institute
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Odyssey Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37087
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37207
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Texas Cancer Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Cancer Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Danville Hematology & Oncology, Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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