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

Telik100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

TLK286DRUG

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

carboplatinDRUG

AUC 6 mg/mL/min Once every 3 weeks

paclitaxelDRUG

200 mg/m² Once every 3 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (52)

Outcomes

Primary Outcomes

Study Objectives

1. To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 2. To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 3. To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin

Time frame: Every 6 Weeks

Data from ClinicalTrials.gov

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Bay Area Cancer Research Group

Concord, California, United States

East Bay Medical Oncology/Hematology Associates

Concord, California, United States

Southwest Cancer Care

Escondido, California, United States