NCT00003441

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with metastatic colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Aug 1998

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

August 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2000

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

September 13, 2004

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

November 1, 1999

Last Update Submit

October 23, 2018

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum6-hydroxymethylacylfulveneMGI-114Irofulven

Outcome Measures

Primary Outcomes (1)

  • Antitumor Activity of MGI-114

    Every 28 day cycle

Study Arms (1)

Irofulven

EXPERIMENTAL

6-hydroxymethylacylfulvene (MGI-114) IV over 5 minutes daily for 5 consecutive days every 28 day cycle.

Drug: Irofulven (MGI-114)

Interventions

Irofulven (MGI-114)DRUG

IV over 5 minutes daily for 5 consecutive days. Courses repeated every 28 days. Minimum treatment period is 2 courses.

Also known as: 6-hydroxymethylacylfulvene, MGI-114
Irofulven

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 lesions Sentinel lesions outside the field of any prior radiation therapy No confirmed or suspected brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No active congestive heart failure No uncontrolled angina At least 6 months since prior myocardial infarction No uncontrolled hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No overt psychosis or mental disability No life threatening illness (unrelated to tumor) PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiation therapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered No concurrent surgery Other: At least 28 days since prior administration of any investigational drug No other concurrent anticancer therapy

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

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

irofulven

Condition Hierarchy (Ancestors)

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

Study Officials

  • Paulo Hoff, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 13, 2004

Study Start

August 1, 1998

Primary Completion

November 8, 2000

Study Completion

November 8, 2000

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

US(1)