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

NCT00697476 | Terminated Phase 1

• 2 other identifiers: ONC-2007-0022008-002125-37
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Small Cell Lung Cancer

Keywords

second line chemotherapy

Outcome Measures

Primary Outcomes (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]

  Limiting tolerated dose (Phase I); efficacy/toxicity after the inclusion of the last patient (Phase II)

Secondary Outcomes (1)

• 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

Study Arms (1)

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

Drug: topotecan, vorinostat

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.

Also known as: Merck Vorinostat

Vorinostat/Topotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Armando Santoro, MD: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan; Vorinostat

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids

Study Officials

• Armando Santoro, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 13, 2008
• Study Start: January 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

IT (1)