Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLC
This study has been terminated.
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas
First received: June 11, 2008
Last updated: May 27, 2013
Last verified: May 2013
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
Small Cell Lung Cancer
Drug: topotecan, vorinostat
||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||Phase I-II Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With Topotecan in Patients With Chemosensitive Recurrent Small Cell Lung Cancer (SCLC)
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] [ Time Frame: Limiting tolerated dose (Phase I); efficacy/toxicity after the inclusion of the last patient (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] [ Time Frame: After the follow up period ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2009 (Final data collection date for primary outcome measure)
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
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.
Other Name: Merck Vorinostat
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697476
|Istituto Clinico Humanitas
|Rozzano, Milan, Italy, 20089 |
Armando Santoro, MD
||Armando Santoro, MD
||Istituto Clinico Humanitas
||Armando Santoro, MD, MD, Istituto Clinico Humanitas
History of Changes
|Other Study ID Numbers:
2008−002125−37 ( EudraCT Number )
|Study First Received:
||June 11, 2008
||May 27, 2013
Keywords provided by Armando Santoro, MD, Istituto Clinico Humanitas:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 22, 2017
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Topoisomerase I Inhibitors
Molecular Mechanisms of Pharmacological Action
Histone Deacetylase Inhibitors