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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00016250
• Other study ID #: 00-139
• Secondary ID: CDR0000068613ROC
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2001
• Last updated: June 17, 2013
• Start date: December 2000
• Est. completion date: June 2002

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2002
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• MKC-1

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,