Small Cell Lung Cancer
Conditions
Keywords
second line chemotherapy
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
Interventions
DRUGtopotecan, 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.
Sponsors
Armando Santoro, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Outcome results
None listed