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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697476
Recruitment Status : Terminated (insufficient enrollment)
First Posted : June 13, 2008
Last Update Posted : May 29, 2013
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas

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

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: topotecan, vorinostat Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : January 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: 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

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

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697476

Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Armando Santoro, MD
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas

Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas Identifier: NCT00697476     History of Changes
Other Study ID Numbers: ONC-2007-002
2008−002125−37 ( EudraCT Number )
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by Armando Santoro, MD, Istituto Clinico Humanitas:
second line chemotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Histone Deacetylase Inhibitors