NCT00016250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2000

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

October 15, 2003

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

1.5 years

First QC Date

May 6, 2001

Last Update Submit

June 17, 2013

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Interventions

MKC-1DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Sunil Sharma, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2001

First Posted

October 15, 2003

Study Start

December 1, 2000

Primary Completion

June 1, 2002

Study Completion

June 1, 2002

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

US(1)