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

Phase 2TerminatedNCT00697476

Armando Santoro, MD2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small Cell Lung Cancer

Interventions

topotecan, vorinostatDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Istituto Clinico Humanitas

Rozzano, Milan, Italy

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]

Time frame: After the follow up period

Data from ClinicalTrials.gov

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