Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer

Sponsor
Third Military Medical University
Study ID
NCT01977235
Phase
PHASE2
Status
Unknown

Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

As the gene polymorphism of uridine diphosphate glucuronosyl transferase 1A1(UGT1A1)is related to the side effect of diarrhea induced by irinotecan. UGT1A1 gene \*28 (6/6 and 6/7) and \*6 (G/G and G/A) is related to low probability of diarrhea and UGT1A1 gene \*28 (7/7) and \*6 (A/A)is related to high probability of diarrhea. The purpose of this study is to find out the efficacy and side effect between two different dosages of irinotecan combined with cisplatin scheme in extensive disease-small cell lung cancer with UGT1A1 gene \*28 (6/6 and 6/7)and \*6 (G/G and G/A), based on the hypothesis that the UGT1A1 gene \*28 (7/7) and \*6 (A/A)is few in the Chinese population and increasing the dose of irinotecan can improve the efficacy without increasing the side effect in the patients with UGT1A1 gene \*28 (6/6 and 6/7)\*6 (G/G and G/A).

Key Dates

Start date
Sep 30, 2013
Status verified
Mar 2016
Primary completion
Feb 28, 2017
Completion
Sep 30, 2017

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Irinotecan 90mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.
  • Active Comparator: Arm B
    Irinotecan 65mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.

Primary Outcome Measure

progression-free survival [ Time Frame: The first day of treatment to the date that disease progression is reported; assessed up to 3 years ]

Central Contacts

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