A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Small Cell Lung Carcinoma

Treatments: Drug: Cisplatin (Or Carboplatin); Drug: Etoposide; Drug: figitumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00977561

A4021032

Details and patient eligibility

About

This study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung Cancer.

Full description

The study prematurely discontinued on January 26, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed diagnosis of extensive stage disease Small Cell Lung Cancer (SCLC), with tumor biopsy sample required.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Total IGF-1 > or = 120 ng/ml

Exclusion criteria

• Any prior systemic therapy for Small Cell Lung Cancer (SCLC)
• HbA1c > or = 5.7%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Arm A

Experimental group

Description:

Figitumumab (CP-751,871) Plus Chemotherapy \[Cisplatin (Or Carboplatin) And Etoposide\] All drugs to be administered on a 21 day cycle

Treatment:

Drug: Etoposide

Drug: Cisplatin (Or Carboplatin)

Drug: Etoposide

Drug: Cisplatin (Or Carboplatin)

Drug: figitumumab

Arm B

Active Comparator group

Description:

Chemotherapy \[Cisplatin (Or Carboplatin) And Etoposide\] All drugs to be administered on a 21 day cycle

Treatment:

Drug: Etoposide

Drug: Cisplatin (Or Carboplatin)

Drug: Etoposide

Drug: Cisplatin (Or Carboplatin)