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Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Yakult Honsha Co., LTD
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00721916
First received: July 23, 2008
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: Until progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: During chemotherapy ] [ Designated as safety issue: Yes ]

Enrollment: 107
Study Start Date: July 2008
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle S-1 40-60 mg bid day 1~day 7 LV 25 mg bid day 1~day 7
Active Comparator: 2
mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle l-LV 200 mg/m2 iv. for 2 hr on day 1 5-FU 400 mg/m2 bolus on day 1 5-FU 2400 mg/m2 ci for 46 hr (day 1, 2hr~48hr)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proved adenocarcinoma (colorectal cancer).
  • Age: 20 ≤ at enrollment.
  • No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded.
  • At least one measurable lesion by RECIST criteria

Exclusion Criteria:

  • Serious drug hypersensitivity.
  • Prior history of peripheral neuropathy.
  • Diarrhea .
  • Simultaneously active double cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721916

Locations
Japan
Shizuoka Cancer Center
Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Yakult Honsha Co., LTD
Investigators
Study Chair: Narikazu Boku, MD St. Marianna University School of Medicine
  More Information

No publications provided

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00721916     History of Changes
Other Study ID Numbers: Taiho10020390
Study First Received: July 23, 2008
Last Updated: October 31, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Oxaliplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014