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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
History of Changes
  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:

U.S. FDA Resources

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
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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Leucovorin
Levoleucovorin
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013