Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Telik
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT00088556
First received: July 29, 2004
Last updated: May 30, 2012
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: TLK286 Drug: carboplatin Drug: paclitaxel |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Telik:
Primary Outcome Measures:
- Study Objectives [ Time Frame: Every 6 Weeks ] [ Designated as safety issue: Yes ]
- 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
| Enrollment: | 100 |
| Study Start Date: | August 2004 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Triplet Combination of TLK286 Carboplatin & Paclitaxel
Experimental
|
Drug: TLK286
Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²
Drug: carboplatin
AUC 6 mg/mL/min Once every 3 weeks
Drug: paclitaxel
200 mg/m² Once every 3 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00088556
Show 52 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088556
Show 52 Study Locations
Sponsors and Collaborators
Telik
More Information
| Responsible Party: | Telik |
| ClinicalTrials.gov Identifier: | NCT00088556 History of Changes |
| Other Study ID Numbers: | TLK286.2023 |
| Study First Received: | July 29, 2004 |
| Last Updated: | May 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Telik:
|
Non-small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Paclitaxel Albumin-Bound Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 28, 2016