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Completed

NCT Number: NCT00388960

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

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Algemeen Ziekenhuis Middelheim, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amrubicin

Drug

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

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

Cisplatin

Drug

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

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 of each 21-day cycle until disease progression.

etoposide

Drug

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 of each 21-day cycle until disease progression.

Primary outcomes

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

    Time frame: Until Disease Progression

Secondary outcomes

  1. Toxicity

    Time frame: Until 30 days after last protocol treatment

  2. Progression-free survival

    Time frame: Until disease progression or death

  3. Overall survival

    Time frame: Until death

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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)

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 17, 2006
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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