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
Stopped early · Phase 1/Phase 2
Conditions studied: Carcinoma, Small Cell
In brief
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.
Key facts
- Study ID
- NCT00537511
- Run by
- Celgene
- People needed
- 22
- Starts
- 2008-02-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2019-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ireland Cancer Center, Case Western Reserve University, Division of Hematology/Oncology — Cleveland, Ohio, United States
- Pennsylvania State University — Hershey, Pennsylvania, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Juranvinski Cancer Center - Medical Oncology — Hamilton, Ontario, Canada
- Princess Margaret Hospital — Toronto, Ontario, Canada
- Mc Gill University - Department of Oncology - Clinical Research Program — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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