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Phase I-II Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With Topotecan in Patients With Chemosensitive Recurrent Small Cell Lung Cancer (SCLC)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

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Trial Information

Phase I-II Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With Topotecan in Patients With Chemosensitive Recurrent Small Cell Lung Cancer (SCLC)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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]

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Armando Santoro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Clinico Humanitas

Authority:

Italy: Ministry of Health

Study ID:

ONC-2007-002

NCT ID:

NCT00697476

Start Date:

January 2009

Completion Date:

January 2010

Related Keywords:

  • Small Cell Lung Cancer
  • second line chemotherapy
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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