Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC) - Full Text View

Purpose

This is a Phase II, open-label, multicenter, single-arm, exploratory “proof of concept” study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive disease after first-line treatment with a platinum-based regimen.

Condition	Intervention	Phase
Small Cell Lung Cancer	Drug: Diflomotecan (BN80915)	Phase II

MedlinePlus related topics:

Cancer Lung Cancer

Drug Information available for:

BN 80915

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase II Open Label Study Investigating the Activity of Diflomotecan (BN80915) Administered at the Fixed Dose of 7mg as a 20 Minute Intravenous Infusion Once Every 3 Weeks in Patients With Sensitive Small Cell Lung Cancer (SCLC) Who Have Failed First-Line Treatment With a Platinum Based Regimen.

Further study details as provided by Ipsen:

Primary Outcome Measures:

Overall objective response rate (tumour assessments should be performed every 6 weeks)

Secondary Outcome Measures:

Time to tumour progression
Time to treatment failure
Duration of overall response
Overall complete response, partial response and stable disease
Time to response
Six month and one year survival rates
Median survival
Best overall response
Overall objective response rate

Estimated Enrollment:	40
Study Start Date:	March 2004
Estimated Study Completion Date:	February 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Documented small cell lung cancer (SCLC)
Measurable disease
One line of previous chemotherapy, including any platinum analogue, and excluding any camptothecin analogues, with objective response and relapsed no less than 3 months

Main Exclusion Criteria:

Uncontrollable brain metastasis
Treated with an investigational drug within 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080015

Sponsors and Collaborators

Ipsen

Investigators


Principal Investigator:	Thierry Le Chevalier, MD	Institut Gustave Roussy, Villejuif, Paris, France

More Information

Study ID Numbers:	2-91-52990-708
First Received:	March 19, 2004
Last Updated:	February 19, 2007
ClinicalTrials.gov Identifier:	NCT00080015
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms

Carcinoma, Neuroendocrine

Carcinoma

Neuroendocrine Tumors

Carcinoma, Small Cell

Neuroectodermal Tumors

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00080015