Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer

Sponsor
University of Toyama
Study ID
NCT00546130
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan hydrochloride — DRUG
    Irinotecan hydrochloride 60 mg/m2, IV (in the vein) on days 1, 8, 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
  • Cisplatin — DRUG
    Cisplatin 60 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
  • Krestin — DRUG
    Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.

Study Details

The purpose of this study is to examine whether setting test groups of cisplatin + irinotecan + Krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy + chemotherapy also allowed) combined with Krestin as second-line treatment after exacerbation and comparing with historical control or community control is appropriate as the protocol and regimen for the phase III clinical trial on extensive-stage disease (ED) small cell lung cancer.

Key Dates

Start date
Nov 30, 2007
Status verified
Aug 2008
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Irinotecan hydrochloride + Cisplatin + Krestin Therapy

Primary Outcome Measure

Overall survival rate [ Time Frame: one year ]

Central Contacts

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