Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer

Celgene

Status and phase: Completed; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Drug: Etoposide; Drug: Amrubicin; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00388960

2006-001956-11 (EudraCT Number)

EORTC Protocol 08062

Details and patient eligibility

About

The purpose of the study is to document the activity and safety of single agent amrubicin, amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line treatment in extensive disease small cell lung cancer.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically/cytologically proven small cell lung cancer
• Extensive disease
• Measurable disease
• World Health Organization (WHO) performance status 0-2
• Age 18 years or older
• Normal baseline cardiac function
• No prior systemic chemotherapy for small cell lung cancer
• Adequate organ function including bone marrow, kidney, and liver
• No history of interstitial lung disease or pulmonary fibrosis
• No history of prior malignancy unless patient has been disease free for greater than 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix
• No pregnancy or breast feeding; patients of child-bearing potential must agree to use an appropriate method of contraception
• Written informed consent before randomization

Exclusion criteria

• Pre-existing peripheral neuropathy (greater than Grade 1, CTCAE version 3.0)
• Uncontrolled or severe cardiovascular disease
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

99 participants in 3 patient groups

Amrubicin

Experimental group

Description:

Amrubicin 45mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.

Treatment:

Drug: Amrubicin

Amrubicin plus Cisplatin

Experimental group

Description:

Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus cisplatin 60mg/m\<2\> IV day 1 of each 21-day cycle until disease progression.

Treatment:

Drug: Cisplatin

Drug: Amrubicin

Cisplatin plus etoposide

Active Comparator group

Description:

Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 each 21-day cycle until disease progression.

Treatment:

Drug: Etoposide

Drug: Cisplatin