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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
S-1, oral Leucovorin, Oxaliplatin
Sponsored by
Shizuoka Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring S-1, oral fluoropyrimidine, tegafur, Gimeracil, Oteracil Potassium, Leucovorin, Calcium Folinate, Oxaliplatin, L-OHP, colorectal cancer

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shizuoka Cancer Center

Outcomes

Primary Outcome Measures

Determine the RD of S-1, Leucovorin, and Oxaliplatin in phase I setting
Evaluate the response rate of S-1, Leucovorin, and Oxaliplatin with recommended dose in phase II

Secondary Outcome Measures

Phase I - Safety - Pharmacokinetic drug-drug interaction - Response rate - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)
Phase II - Safety - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)

Full Information

First Posted
September 4, 2007
Last Updated
November 12, 2008
Sponsor
Shizuoka Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00524706
Brief Title
Phase I/II Study of SOL for Untreated Metastatic Colorectal Cancer
Official Title
Phase I/II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) in Patients With Untreated Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shizuoka Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Introduction: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
S-1, oral fluoropyrimidine, tegafur, Gimeracil, Oteracil Potassium, Leucovorin, Calcium Folinate, Oxaliplatin, L-OHP, colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
S-1, oral Leucovorin, Oxaliplatin
Primary Outcome Measure Information:
Title
Determine the RD of S-1, Leucovorin, and Oxaliplatin in phase I setting
Time Frame
During 2 cycles
Title
Evaluate the response rate of S-1, Leucovorin, and Oxaliplatin with recommended dose in phase II
Time Frame
During chemotherapy
Secondary Outcome Measure Information:
Title
Phase I - Safety - Pharmacokinetic drug-drug interaction - Response rate - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)
Title
Phase II - Safety - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narikazu Boku, MD
Organizational Affiliation
Shizuoka Cancer Cener, Division of Gastrointestinal Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan

12. IPD Sharing Statement

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

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