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

Sponsor
Armando Santoro, MD
Study ID
NCT00697476
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • topotecan, vorinostat — 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.

Study Details

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

Key Dates

Start date
Jan 31, 2009
Status verified
May 2013
Primary completion
Sep 30, 2009
Completion
Jan 31, 2010

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

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) ]

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