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

Celgene

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Carcinoma, Small Cell

Treatments: Drug: Pomalidomide; Drug: Cisplatin; Drug: Etoposide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00537511

CC-4047-SCLC-002

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Dose-finding arm: Pomalidomide + Cisplatin + Etoposide

Experimental group

Description:

Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.

Treatment:

Drug: Etoposide

Drug: Cisplatin

Drug: Pomalidomide