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Clinical Trials/EUCTR2007-001069-14-DE
EUCTR2007-001069-14-DE
Active, not recruiting
Not Applicable

A phase II open-label, multi-centre, randomised, prospective, parallel-group study comparing Topotecan/Carboplatin administered 5 days versus 3 days versus Topotecan monotherapy daily x 5 as second line treatment for patients with relapsed extensive disease small cell lung cancer - Top Challenge

Aktion Bronchialkarzinom e.V.0 sitesNovember 14, 2007
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ConditionsProspective randomized multi-center open label phase II study to determine the antitumoral activity and the feasibility of a combination therapy with Hycamtin/Carboplatin administered 5-days versus 3-days versus Topotecan monotherapy 5-days as second line treatment for patients with histological or cytological verified relapse or progression of extensive disease small cell lung cancer, documented later than 60 days after day 1 of the last cycle of first-line therapy.MedDRA version: 9.1Level: LLTClassification code 10041068Term: Small cell lung cancer extensive stage
DrugsHycamtin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prospective randomized multi-center open label phase II study to determine the antitumoral activity and the feasibility of a combination therapy with Hycamtin/Carboplatin administered 5-days versus 3-days versus Topotecan monotherapy 5-days as second line treatment for patients with histological or cytological verified relapse or progression of extensive disease small cell lung cancer, documented later than 60 days after day 1 of the last cycle of first-line therapy.
Sponsor
Aktion Bronchialkarzinom e.V.
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 14, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Aktion Bronchialkarzinom e.V.

Eligibility Criteria

Inclusion Criteria

  • •Pre\-treated histologically confirmed small cell lung cancer (cytological diagnoses is
  • •permitted only in definitely and doubtless cases)
  • •Relapse or progression of small cell lung cancer at least 60 days after day 1 of
  • •the last cycle of first\-line therapy.
  • •ECOG Performance Status \< 2
  • •Life expectancy not less than 2 month
  • •No contraindication against any study medication used in this study
  • •No more than one previous chemotherapy with a minimum of 4 and a maximum of
  • •6 cycles. The previous chemotherapy had to be platin\-based.
  • •Age \= 18 years

Exclusion Criteria

  • •Patients without a previous chemotherapy
  • •More than one previous chemotherapy
  • •Patients with a previous radiotherapy (\>25% Irradiation of bone marrow) within
  • •6 weeks prior to study start
  • •Other co\-existing malignancies or malignancies diagnosed within the last 5 years
  • •with the exception of non\-melanomatous skin cancer or cervical carcinoma of the
  • •cervix after curative therapy.
  • •Pregnancy or lactation period or lack of effective contraception
  • •Active infections prior to study start
  • •Respiratory insufficiency

Outcomes

Primary Outcomes

Not specified

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