Clinical trial NCT00537511: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Small Cell
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: Cycle 1 (21 days)
Secondary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase
timeFrame: Cycles 1 - 6 (21-day cycles)
measure: Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Cycles 1 -6 (21-day cycles)
measure: Duration of Response
timeFrame: From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)
measure: Overall Survival
timeFrame: From enrollment through study termination (approximately 35 months)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
timeFrame: Cycles 1-6 (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6).
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase
timeFrame: Cycle 7 to discontinuation (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide during Maintenance Phase was 5.0 (1.1, 36.0).
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center, Case Western Reserve University, Division of Hematology/Oncology
state: Ohio
city: Hershey
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Hamilton
country: Canada
facility: Juranvinski Cancer Center - Medical Oncology
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Mc Gill University - Department of Oncology - Clinical Research Program
state: Quebec
Study officials:
affiliation: Celgene Corporation
name: Ulf Jungnelius, MD
role: STUDY_DIRECTOR
References:
citation: Ellis PM, Jungnelius U, Zhang J, Fandi A, Beck R, Shepherd FA. A phase I study of pomalidomide (CC-4047) in combination with cisplatin and etoposide in patients with extensive-stage small-cell lung cancer. J Thorac Oncol. 2013 Apr;8(4):423-8. doi: 10.1097/JTO.0b013e318282707b.