Phase I Safety and Tolerability Study of Cediranib (RECENTIN™, AZD2171) in Combination With Chemo in First Line Lung Cancer Patients

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Lung Cancer

Treatments: Drug: Etoposide; Drug: AZD2171; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621361

D8480C00054

Details and patient eligibility

About

This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in combination with etoposide and cisplatin (EP) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom EP would be a standard therapy.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cancer diagnosis and stage (histological or cytological confirmed extensive stage lung cancer, which EP would be considered a standard therapy, required at the time of diagnosis.)
• No prior chemotherapy or immunotherapy for advanced stage lung cancer (prior radiotherapy will be permitted if it is outside of the measurable field and greater than or equal to 2 weeks prior to entry to the study.)
• WHO performance status 0-2

Exclusion criteria

• Untreated unstable brain or meningeal metastases
• Patient with inappropriate laboratory tests values
• Inadequate bone marrow reserve.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: AZD2171

2

Active Comparator group

Description:

Etoposide + Cisplatin

Treatment:

Drug: Cisplatin

Drug: Etoposide