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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Study Objectives

Outcome 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

Outcome Time Frame:

Every 6 Weeks

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

TLK286.2023

NCT ID:

NCT00088556

Start Date:

August 2004

Completion Date:

May 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-small cell lung cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Dakota Cancer InstituteFargo, North Dakota  58103-4940
Massachusetts General HospitalBoston, Massachusetts  02114-2617
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Southwest Cancer CarePoway, California  92064
Kaiser Permanente Medical CenterVallejo, California  94589
Texas Cancer AssociatesDallas, Texas  75231
Bay Area Cancer Research GroupConcord, California  94520
Danville Hematology & Oncology, Inc.Danville, Virginia  24541
Kansas City Cancer CenterKansas City, Missouri  64111
LSU Health Sciences CenterShreveport, Louisiana  71130-3932
Kansas City Cancer CenterKansas City, Kansas  66112
Horizons West Medical GroupScottsbluff, Nebraska  69361
Odyssey ResearchBismarck, North Dakota  58501
East Bay Medical Oncology/Hematology AssociatesConcord, California  94520
Diablo Valley Oncology & Hematology Medical GroupWalnut Creek, California  94520
Citrus Hematology and OncologyCrystal River, Florida  34429
Citrus Hematology and Oncology CenterInverness, Florida  34452
Florida Wellcare Alliance, LCInverness, Florida  34452
Kansas City Cancer Center - Central Research Dept. Data Office & Drug Discovery LocationLenexa, Kansas  66214
Department of Veterns Affairs - Overton Brooks VA Medical CenterShreveport, Louisiana  71101
University of Maryland, Baltimore University of Maryland Medical System-Greenebaum Cancer CenterBaltimore, Maryland  21201
Center for Cancer and Blood Disorders, P. C.Bethesda, Maryland  20817
Brigham & Women's HospitalBoston, Massachusetts  02115
St. John's Mercy HospitalWashington, Missouri  63090
Clinical Research ServiceScottsbluff, Nebraska  69361
Tennessee Oncology, PLLCClarksville, Tennessee  37043