Overview

A Phase I/II Study to Determine the Maximum Tolerated Dose (MTD) and Safety of CC-4047 (Pomalidomide) Administered in Conjunction With Cisplatin and Etoposide

Status:
Terminated
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the maximum tolerated dose and safety of CC-4047 (pomalidomide) given in combination with cisplatin and etoposide in patients with extensive disease small cell lung cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Celgene
Celgene Corporation
Treatments:
Cisplatin
Etoposide
Etoposide phosphate
Pomalidomide
Thalidomide
Criteria
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