Clinical trial NCT00088556: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-small cell lung cancer
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2004-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Study Objectives
timeFrame: Every 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Concord
country: United States
facility: East Bay Medical Oncology/Hematology Associates
state: California
city: Escondido
country: United States
facility: Southwest Cancer Care
state: California
city: Hayward
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Murrieta
country: United States
facility: Southwest Cancer Care
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Poway
country: United States
facility: Southwest Cancer Care
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: San Jose
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: So. San Francisco
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Valley Oncology & Hematology Medical Group
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Crystal River
country: United States
facility: Citrus Hematology and Oncology
state: Florida
city: Inverness
country: United States
facility: Citrus Hematology and Oncology Center
state: Florida
city: Inverness
country: United States
facility: Florida Wellcare Alliance, LC
state: Florida
city: Kansas City
country: United States
facility: Kansas City Cancer Center
state: Kansas
city: Lenexa
country: United States
facility: Kansas City Cancer Center - Central Research Dept. Data Office & Drug Discovery Location
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Cancer Center
state: Kansas
city: Shreveport
country: United States
facility: Department of Veterns Affairs - Overton Brooks VA Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Baltimore University of Maryland Medical System-Greenebaum Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders, P. C.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Kansas City
country: United States
facility: Kansas City Cancer Center
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Cancer Center
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Cancer Center
state: Missouri
city: Lee's Summit
country: United States
facility: Kansas City Cancer Center
state: Missouri
city: St. Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Washington
country: United States
facility: St. John's Mercy Hospital
state: Missouri
city: Scottsbluff
country: United States
facility: Clinical Research Service
state: Nebraska
city: Scottsbluff
country: United States
facility: Horizons West Medical Group
state: Nebraska
city: Fargo
country: United States
facility: Dakota Cancer Institute
state: North Dakota
city: Fargo
country: United States
facility: Odyssey Research
state: North Dakota
city: Clarksville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Franklin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Hermitage
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Lebanon
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Murfreesboro
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Smyrna
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Dallas
country: United States
facility: Texas Cancer Associates
state: Texas
city: Plano
country: United States
facility: Texas Cancer Associates
state: Texas
city: Danville
country: United States
facility: Danville Hematology & Oncology, Inc.
state: Virginia
Study officials:
References: