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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Small Cell

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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/┬ÁL

- 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