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Randomized Phase II Study of Amrubicin as Single Agent or in Combination With Cisplatin Versus Etoposide-cisplatin as First-line Treatment in Patients With Extensive Stage SCLC (ES)


Phase 2
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

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Trial Information

Randomized Phase II Study of Amrubicin as Single Agent or in Combination With Cisplatin Versus Etoposide-cisplatin as First-line Treatment in Patients With Extensive Stage SCLC (ES)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)

Outcome Time Frame:

Until Disease Progression

Safety Issue:

No

Principal Investigator

Mary O'Brien, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden Hospital, London, UK

Authority:

European Union: European Medicines Agency

Study ID:

EORTC Protocol 08062

NCT ID:

NCT00388960

Start Date:

November 2006

Completion Date:

December 2010

Related Keywords:

  • Small Cell Lung Cancer
  • small cell lung cancer
  • amrubicin
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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