Satraplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

Phase 2 Trial of First-Line Therapy With Satraplatin and Paclitaxel in Patients With Unresectable Stage III or IV Non-small Cell Lung Cancer (NSCLC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00268970

Enrollment

Registered

2005-12-23

Start date

2005-12-31

Completion date

2009-09-30

Last updated

2012-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Advanced non-small cell lung cancer (NSCLC)

Brief summary

The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

Detailed description

This trial is designed to study the efficacy and safety of a novel oral platinum analog, satraplatin, in combination with another chemotherapy drug, paclitaxel, for the first line of treatment (patients who have not received chemotherapy for disease that has metastasized) of patients with advanced NSCLC. WHAT IS SATRAPLATIN: Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Interventions

DRUGSatraplatin in combination with Paclitaxel

Paclitaxel 200 mg/m2 IV over 3 hours on day 1. Satraplatin 60 mg/m2 administered by mouth once daily for 5 consecutive days (days 1-5). Satraplatin will be administered within 2 hours following paclitaxel infusion on day 1. Subsequent doses on days 2-5 will be taken at approximately 24 hour intervals.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed advanced NSCLC * Patients must not have received any prior antineoplastic chemotherapy or investigational product for lung cancer prior to study entry. * Patients must have at least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan. * ECOG performance status of ≤ 2.

Design outcomes

Primary

Measure	Time frame
To examine overall response rates in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel	3 months

Secondary

Measure	Time frame
To examine time to tumor progression, overall survival, and safety in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026