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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-01

Study Completion Date

2010-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Small Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose-finding arm: Pomalidomide + Cisplatin + Etoposide

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.

Group Type EXPERIMENTAL

Pomalidomide

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Interventions

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Pomalidomide

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Other Intervention Names

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CC-4047 Pomalyst Cisplatinum CDDP Platin Etoposide phosphate VP-16 Etopophos

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No