NCT00043927|CompletedPhase 3

Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer.

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

104864-A/389

Study Type

interventional

Target

760

Locations

33 countries

Sites

174

Timeline

RegisteredAug 2002

StartedApr 2001

Brief Summary

This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

760

participants targeted

Target at P75+ for phase_3

Geographic Reach

33 countries

174 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed

1.4 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2002

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2002

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed

Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

2.8 years

First QC Date

August 14, 2002

Last Update Submit

August 20, 2013

Conditions

Small Cell Lung Cancer

Keywords

Chemotherapy-naiveSmall Cell Lung CancerSCLCExtensive diseaseEDtopotecanHycamtinoral

Outcome Measures

Primary Outcomes (1)

Overall Survival

Secondary Outcomes (1)

response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients

Interventions

topotecan/cisplatinDRUG

etoposide/cisplatinDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent (patient's written understanding of and agreement to participate in this study).
Patients with confirmed extensive small cell lung cancer (SCLC).
No prior chemotherapy within 5 years of the diagnosis of SCLC.
Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).
At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

You may not qualify if:

Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
Any active infection.
Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
Use of an investigational drug within 30 days before the first dose of study medication.
Women who are pregnant or lactating.
Patients of child-bearing potential who refuse to practice an adequate form of birth control.
Patients with clinical evidence of any stomach or intestinal (GI) condition.
Patients requiring treatment with the drug cyclosporin A.

Contact the study team to confirm eligibility.