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Ro 31-7453 in Treating Patients With Recurrent or Refractory 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.
ClinicalTrials.gov Identifier: NCT00016250
Recruitment Status : Completed
First Posted : October 15, 2003
Last Update Posted : June 18, 2013
Information provided by:

Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of Ro 31-7453 in treating patients who have recurrent or refractory metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: MKC-1 Phase 2

Detailed Description:


  • Compare the objective disease rate of patients with recurrent or refractory metastatic colorectal cancer treated with two dose schedules of Ro 31-7453.
  • Compare the safety and tolerability of these regimens in these patients.
  • Compare the response duration in patients treated with these regimens.
  • Compare the time to progression and time to treatment failure in patients treated with these regimens.
  • Determine the pharmacokinetic profiles of Ro 31-7453 and its major metabolites in these patients.
  • Compare the overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive oral Ro 31-7453 twice daily on days 1-4. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive oral Ro 31-7453 twice daily on days 1-14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 28 days and then every 3 months.

PROJECTED ACCRUAL: Approximately 160 patients (49 per treatment arm plus 61 additional patients in the arm determined to be most effective) will be accrued for this study within 1 year.

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Two Shcedules of Ro 31-7453 in Patients With Metastatic (Dukes' D) Colorectal Carcinoma (CRC) Who Have Failed Both Fluoropyrimidine and Irinotecan Chemotherapy
Study Start Date : December 2000
Primary Completion Date : June 2002
Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic adenocarcinoma of the colon or rectum
  • Bidimensionally measurable disease

    • At least 2.0 x 2.0 cm
  • Failed prior fluoropyrimidine and irinotecan chemotherapy in adjuvant or metastatic setting

    • Must have had disease progression while receiving chemotherapy OR
    • If received fluorouracil with or without irinotecan in adjuvant setting, must also have failed therapy with these agents in metastatic setting (unless manifesting metastatic disease during adjuvant therapy)
  • No known CNS metastases



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • Hemoglobin at least 9 g/dL
  • Absolute neutrophil count at least 1,500/mm^3
  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2.5 ULN (5 times ULN if bone or liver metastases present)


  • Creatinine no greater than 1.5 times ULN


  • No New York Heart Association class III or IV congestive heart failure
  • No myocardial infarction within the past 6 months


  • No bowel obstruction
  • No active uncontrolled malabsorption syndrome


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection
  • No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer
  • No other active cancers, including stable disease on adjuvant therapy
  • No other medical condition that would preclude study


Biologic therapy:

  • See Chemotherapy
  • At least 2 weeks since prior biologic therapy and recovered


  • See Disease Characteristics
  • No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease
  • Monoclonal antibody (MOAB) therapy and antiangiogenic agents not included as prior cytotoxic chemotherapy
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

  • Not specified


  • At least 3 weeks since prior radiotherapy and recovered


  • No prior total gastrectomy


  • No other concurrent investigational agents
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00016250

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Sunil Sharma, MD Memorial Sloan Kettering Cancer Center
More Information

ClinicalTrials.gov Identifier: NCT00016250     History of Changes
Other Study ID Numbers: 00-139
CDR0000068613 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 15, 2003    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

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