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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00697476
• Other study ID #: ONC-2007-002
• Secondary ID: 2008-002125-37
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: June 11, 2008
• Last updated: May 27, 2013
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: May 2013
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Armando Santoro, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]		Limiting tolerated dose (Phase I); efficacy/toxicity after the inclusion of the last patient (Phase II)	Yes
Secondary	To assess the antitumor activity of the combination in terms of time to progression (TTP) and overall survival (OS) [Phase II]		After the follow up period	No