Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00088556 |
Recruitment Status
:
Completed
First Posted
: July 30, 2004
Last Update Posted
: May 31, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung | Drug: TLK286 Drug: carboplatin Drug: paclitaxel | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | August 2004 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
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
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- Study Objectives [ Time Frame: Every 6 Weeks ]
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088556

Responsible Party: | Telik |
ClinicalTrials.gov Identifier: | NCT00088556 History of Changes |
Other Study ID Numbers: |
TLK286.2023 |
First Posted: | July 30, 2004 Key Record Dates |
Last Update Posted: | May 31, 2012 |
Last Verified: | June 2011 |
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 |