Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer

This study has been completed.
Information provided by:
Memorial Sloan-Kettering Cancer Center Identifier:
First received: May 6, 2001
Last updated: June 17, 2013
Last verified: June 2013

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 Intervention Phase
Colorectal Cancer
Drug: MKC-1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: December 2000
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: 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
Study Chair: Sunil Sharma, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided Identifier: NCT00016250     History of Changes
Other Study ID Numbers: 00-139, CDR0000068613, ROCHE-16113, ROCHE-RO31-7453, NCI-G01-1945
Study First Received: May 6, 2001
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

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 processed this record on April 17, 2014