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Carboplatin and Etoposide Plus LBH589 for Small Cell Lung Cancer

NCT00958022 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-06-22

No results posted yet for this study

Summary

The subjects are being asked to take part in the Phase I or Phase II portion of a research study of a new investigational drug, LBH589, in combination with chemotherapeutic agents, carboplatin with etoposide. LBH589 (made by Novartis Pharmaceuticals Corp.) is considered "investigational" because it has not been approved for commercial use in the treatment of cancer by the U.S. Food and Drug Administration (FDA). Etoposide and carboplatin are chemotherapeutic agents approved by the FDA for the treatment of for small cell lung cancer.

LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes (proteins produced by cells). LBH589 has shown effects against cancer in laboratory studies and in studies using animals; however, it is not known if this medicine will show the same activity in humans. As of May 2006, approximately 100 patients have received treatment with either an intravenous or capsule form of LBH589. Only the capsule form of LBH589 will be used in this study.

The main goal during the Phase I portion of this research study is to find out the highest and safest dose of LBH589 that can be given in combination with carboplatin with etoposide in subjects with lung cancer without causing severe side effects. The main goal of the Phase II portion of this study is to find how the subject's lung cancer responds to the LBH589 in combination with carboplatin and etoposide at the highest and safest dose that was given in Phase I.

The subject may be enrolled in either Phase I or Phase II of the trial, depending on when they entered the study, but they will not be enrolled in both phases.

This study will also investigate how the subject's body processes the combination of LBH589 and carboplatin with etoposide. To determine this, the investigators will measure the amount of study drug in the subject's blood. This will be done with a series of blood tests, called pharmacokinetic (PK) tests. Pharmacokinetics is the study of how the study drug moves through the body. Other purposes of this study will be to sample the subject's genetic material (DNA/RNA) as well as to determine biomarkers in their blood. (For some cancers, biomarkers are a way to measure the extent of their disease or the effects of treatment.) These samples will also be stored for future studies.

Conditions

Interventions

DRUG

LBH589 and carboplatin with etoposide

LBH589 will be given in oral formulation starting at a dose of 10 mg (Dose Level 1) 3x/week (2 days apart, e.g. Mon, Wed, Fri), during 2 weeks out of 3-weekly dosing schedule. After establishing the MTD at a 2 out 3 weeks dosing schedule, a 3 out of 3 weeks dosing schedule will be tested at that dose. This schedule will be adopted in the absence of limiting toxicities. Will be continued weekly after completion of 6 cycles of combo chemotherapy until progression or intolerable toxicities. Etoposide: Cycles 1-6: 100 mg/m² IV over 60 mins, Days 1-3 every 21 days for 6 cycles Carboplatin: commercially available as a sterile lyophilized powder available in single dose vials containing 50mg, 150mg, or 450mg of carboplatin. Each vial contains equal parts by weight of carboplatin \& mannitol. Commercial supplies will be used for this study. It will be administered as an i.v. infusion over 30 minutes. The dose will be calculated based on patient's body weight at each treatment visit.

Sponsors & Collaborators

Principal Investigators

  • Ahmad A Tarhini, MD · UPMC/UPCI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00958022 on ClinicalTrials.gov