A Multicenter, Phase I/IIA, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose and To Evaluate the Safety Profile of CC-4047 Administered in Combination With Cisplatin and Etoposide in Patients With Extensive Disease Small Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Small Cell
Trial Information
A Multicenter, Phase I/IIA, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose and To Evaluate the Safety Profile of CC-4047 Administered in Combination With Cisplatin and Etoposide in Patients With Extensive Disease Small Cell Lung Cancer
Inclusion Criteria:
- signature of informed consent
- Age >= 18
- histologically or cytologically confirmed small cell lung cancer (SCLC)
- extensive stage SCLC
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
- brain metastases that are asymptomatic and do not require steroid control
- females of child bearing potential must use two forms of birth control
Exclusion Criteria:
- pregnant or lactating females
- prior use of cytotoxic chemotherapy
- surgery within 14 days of study
- radiation within 14 days of study
- prior therapy with CC-4047 (pomalidomide), lenalidomide or thalidomide
- concurrent use or anticipated use of anti-cancer agents
- absolute neutrophil count (ANC) < 1500/mm^3
- platelets < 100 x 10^3/µL
- serum creatinine >2.5 mg/dL
- serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase
(SGPT) > 3.0 x upper limit of normal (ULN)
- serum total bilirubin > 1.8 mg/dL
- uncontrolled hypercalcemia
- creatinine clearance <50 mL/min
- uncontrolled hypertension
- neuropathy >= grade 2
- body mass index (BMI) >= 40
- any other active invasive malignancy requiring treatment
- known chronic infection with human immunodeficiency virus (HIV), hepatitis B virus
(HBV) or hepatitis C virus (HCV)
- inability or unwillingness to comply with birth control requirements
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 (MTD)
Outcome Description:
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment. The MTD Phase included the Treatment period (Cycle 1: Identification of the MTD) and the Extension period (Cycles 2 to 6: Confirmation of Safety of the MTD). (See Secondary Outcome Measure 2 for data on DLTs.)
Outcome Time Frame:
Cycle 1 (21 days)
Safety Issue:
Yes
Principal Investigator
Ulf Jungnelius, MD
Investigator Role:
Study Director
Investigator Affiliation:
Celgene Corporation
Authority:
United States: Food and Drug Administration
Study ID:
CC-4047-SCLC-002
NCT ID:
NCT00537511
Start Date:
February 2008
Completion Date:
December 2010
Related Keywords:
- Carcinoma, Small Cell
- Carcinoma
- Carcinoma, Small Cell
Name | Location |
|---|---|
| University of Texas Southwestern Medical Center | Dallas, Texas |
| Pennsylvania State University | Hershey, Pennsylvania 17033 |
| Ireland Cancer Center, Case Western Reserve University, Division of Hematology/Oncology | Cleveland, Ohio 44106 |
