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

Primary Purpose

Small Cell Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
topotecan, vorinostat
Sponsored by
Armando Santoro, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring second line chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Istituto Clinico Humanitas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vorinostat/Topotecan

Arm Description

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

Outcomes

Primary Outcome Measures

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]

Secondary Outcome Measures

To assess the antitumor activity of the combination in terms of time to progression (TTP) and overall survival (OS) [Phase II]

Full Information

First Posted
June 11, 2008
Last Updated
May 27, 2013
Sponsor
Armando Santoro, MD
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1. Study Identification

Unique Protocol Identification Number
NCT00697476
Brief Title
Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLC
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 Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
insufficient enrollment
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Armando Santoro, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
second line chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vorinostat/Topotecan
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
topotecan, vorinostat
Other Intervention Name(s)
Merck Vorinostat
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

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

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