Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLC

This study has been terminated.

(insufficient enrollment)

Sponsor:

Information provided by (Responsible Party):

Armando Santoro, MD, Istituto Clinico Humanitas

ClinicalTrials.gov Identifier:

NCT00697476

First received: June 11, 2008

Last updated: August 31, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 11, 2008

Last Updated Date

August 31, 2011

Start Date ^ICMJE

January 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum tolerated dose of the combination as the recommended dose for phase II trial [Phase I]; objective response rate of the combination [Phase II]; toxicity and safety profile of the combination [Phase II] [ Time Frame: Limiting tolerated dose (Phase I); efficacy/toxicity after the inclusion of the last patient (Phase II) ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00697476 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the antitumor activity of the combination in terms of time to progression (TTP) and overall survival (OS) [Phase II] [ Time Frame: After the follow up period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLC

Official Title ^ICMJE

Phase I-II Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With Topotecan in Patients With Chemosensitive Recurrent Small Cell Lung Cancer (SCLC)

Brief Summary

The purpose of this study is to evaluate the maximum tolerated dose, the activity and the safety profile of the combination of vorinostat and topotecan in patients with recurrent small cell lung cancer

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Small Cell Lung Cancer

Intervention ^ICMJE

Drug: topotecan, vorinostat

Phase I study: vorinostat will be administered daily for a number of days per cycle variable from 7 to 14 according to the level of dose escalation; topotecan will be administered I.V. for 5 consecutive days every 3 weeks.

Phase II study: Patients will receive treatment at the recommended dose established by phase I part of the trial, for a maximum of 6 cycles or until disease progression, unacceptable toxicity or patient's refusal.

Other Name: Merck Vorinostat

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2010

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologically or cytologically proven diagnosis of SCLC;
Limited or extensive-stage disease in patients who have received a single chemotherapy regimen or combined modality (chemotherapy + chest radiotherapy) regimen and relapsed after completion of first-line chemotherapy (sensitive relapse);
Age >/= 18 years;
ECOG Performance Status 0-2;
Life expectancy of at least 12 weeks;
Measurable lesions according to RECIST criteria;
Adequate cardiac, hepatic, renal, and bone marrow function;
Written informed consent.

Exclusion Criteria:

Prior treatment with an HDAC inhibitor;
Symptomatic and/or unstable pre-existing brain metastases;
Superior Vena Cava Syndrome;
Spinal cord compression;
Severe or uncontrolled medical diseases (Hypertension, diabetes, congestive heart failure, myocardial infarction within 6 months of study, chronic renal disease, or active uncontrolled infections);
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ;
Pregnant or breastfeeding women.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00697476

Other Study ID Numbers ^ICMJE

ONC-2007-002, 2008−002125−37

Has Data Monitoring Committee

Responsible Party

Armando Santoro, MD, Istituto Clinico Humanitas

Study Sponsor ^ICMJE

Armando Santoro, MD

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Armando Santoro, MD

Istituto Clinico Humanitas

Information Provided By

Istituto Clinico Humanitas

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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