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

NCT ID: NCT00697476

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-01-31

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

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vorinostat/Topotecan

Vorinostat/topotecan dose escalation regimen. vorinostat is administered orally once a day for 7 to 14 consecutive days, according to the dose level.Topotecan is administered I.V. for 5 consecutive days every three weeks.

Vorinostat dose levels go from 300 mg/day for 7 days to 400 mg/day for 14 days. Topotecan dose levels go from 1,2 mg/m2 to 1,5 mg/m2

Group Type: EXPERIMENTAL

topotecan, vorinostat

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Merck Vorinostat

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Armando Santoro, MD

OTHER

Sponsor Role: lead

Responsible Party

Armando Santoro, MD

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Armando Santoro, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Countries

Italy

Other Identifiers

2008-002125-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ONC-2007-002

Identifier Type: -

Identifier Source: org_study_id