search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MKC-1
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: 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 Hepatic: 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) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV congestive heart failure No myocardial infarction within the past 6 months Gastrointestinal: No bowel obstruction No active uncontrolled malabsorption syndrome Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy At least 2 weeks since prior biologic therapy and recovered Chemotherapy: 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 Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: No prior total gastrectomy Other: No other concurrent investigational agents

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
June 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00016250
Brief Title
Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MKC-1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: 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 Hepatic: 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) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV congestive heart failure No myocardial infarction within the past 6 months Gastrointestinal: No bowel obstruction No active uncontrolled malabsorption syndrome Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy At least 2 weeks since prior biologic therapy and recovered Chemotherapy: 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 Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: No prior total gastrectomy Other: No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Sharma, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs