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Clinical Trials/NCT00697476
NCT00697476TerminatedPhase 1

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

Armando Santoro, MD1 site in 1 country2 target enrollmentStarted: January 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Sponsor
Enrollment
2
Locations
1
Primary Endpoint
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]

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

Vorinostat/Topotecan

Experimental

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: topotecan, vorinostat (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Investigators

Sponsor
Armando Santoro, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Armando Santoro, MD

MD

Istituto Clinico Humanitas

Study Sites (1)

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