Phase I/II Study of SOL for Untreated Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00524706
Recruitment Status : Unknown
Verified November 2008 by Shizuoka Cancer Center.
Recruitment status was:  Active, not recruiting
First Posted : September 5, 2007
Last Update Posted : November 13, 2008
Information provided by:
Shizuoka Cancer Center

Brief Summary:


S-1 is promising drug which could replace 5-fluorouracil plus l-leucovorin (5-FU/l-LV) in treatment of advanced colorectal cancer.

Phase I/II study of S-1 plus Oxaliplatin (SOX) demonstrated its promising activity with acceptable toxicity as first-line chemotherapy in patients with untreated metastatic colorectal cancer and S-1 showed equivalent possibility to 5-FU/l-LV. On the other hand, phase I/II study of S-1 plus oral Leucovorin (S-1/LV) demonstrated that this regimen had enhanced efficacy in comparison with S-1 alone. From these results, it was expected that S-1/LV plus Oxaliplatin (SOL) would be more effective than SOX.

Therefore, phase I/II study of SOL combination therapy was planned.

Purpose A dose-finding study of S-1/LV plus Oxaliplatin (SOL) was planned to determine the recommended dose (RD), and to assess the response rate (RR) in patients with untreated metastatic colorectal cancer. The primary endpoints of the phase I portion are determination of the RD of SOL, and safety.

The phase II portion of this study was aimed to assess the RR of SOL.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: S-1, oral Leucovorin, Oxaliplatin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) in Patients With Untreated Metastatic Colorectal Cancer
Study Start Date : August 2007
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Primary Outcome Measures :
  1. Determine the RD of S-1, Leucovorin, and Oxaliplatin in phase I setting [ Time Frame: During 2 cycles ]
  2. Evaluate the response rate of S-1, Leucovorin, and Oxaliplatin with recommended dose in phase II [ Time Frame: During chemotherapy ]

Secondary Outcome Measures :
  1. Phase I - Safety - Pharmacokinetic drug-drug interaction - Response rate - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)
  2. Phase II - Safety - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent.
  • Adequate oral intake.
  • Histologically proved adenocarcinoma (colorectal cancer).
  • Unresectable, recurrent and advanced colorectal cancer.
  • At least 4 weeks since prior major surgery
  • Age: 20 - 74 at enrollment.
  • Performance Status (Eastern Cooperative Oncology Group [ECOG] scale): 0 - 2.
  • 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.
  • Proved presence of measurable lesions within 30 days before enrollment.
  • Patients with the following function of bone marrow, liver and kidney based on the laboratory values measured within 15 days before enrollment.

    • Hemoglobin >_ 9.0g/dL
    • WBC: LLN - 12,000/mm3
    • Absolute granulocyte count >_ 1,500/mm3
    • Platelets >_ 100,000/mm3
    • Total Bilirubin <_ 1.5mg/dL
    • AST(GOT) and ALT(GPT) <_ 100U/L
    • ALP <_ 600U/L
    • Creatinine <_ 1.0mg/dl
  • Expected to survive more than 90 days after enrollment.

Exclusion Criteria:

  • Patients who not received S-1 and Oxaliplatin as neoadjuvant or adjuvant chemotherapies before enrollment.
  • Contraindication to S-1, and serious hypersensitivity to oral Leucovorin.
  • No other concurrent investigational therapy.
  • Patients did who not received blood transfusion and hematogenesis stimulating agents (ex. Granulocyte-Colony Stimulating Factor).
  • Serious drug hypersensitivity.
  • Prior history of peripheral neuropathy.
  • Marked infection or inflammation (ex. patients with a fever of 38.0 degrees or higher).
  • Poorly-controlled diabetes, hypertension or hypercalcemia.
  • Severe (inpatient care is needed) arrhythmia, heart disease or its history.
  • Severe (inpatient care is needed) lung disease (ex. interstitial pneumonia or pulmonary fibrosis).
  • Psychiatric disorder requiring to receive treatment with antipsychotic drug.
  • Fresh bleeding from the gastrointestinal tract.
  • Requiring to drainage massive ascites, pleural effusion retention or pericardial fluid.
  • Extensive bone metastasis.
  • Clinically suspicious brain metastasis or brain metastasis.
  • Diarrhea (watery diarrhea).
  • Simultaneously active double cancer.
  • Pregnancy or nursing female patients and possibility (intent) to bear baby. Male patients with intent to impregnate.
  • Other patients evaluated to be inadequate to participate in the study by (sub) investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00524706

Shizuoka Cancer Center
Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Shizuoka Cancer Center
Principal Investigator: Narikazu Boku, MD Shizuoka Cancer Cener, Division of Gastrointestinal Oncology Identifier: NCT00524706     History of Changes
Other Study ID Numbers: SCC-07-01
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: November 2008

Keywords provided by Shizuoka Cancer Center:
oral fluoropyrimidine
Oteracil Potassium
Calcium Folinate
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents