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Phase II Study of MGI-114 (NSC# 683863) Administered Intravenously for Five Days Every 28 Days to Patients With Metastatic Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Phase II Study of MGI-114 (NSC# 683863) Administered Intravenously for Five Days Every 28 Days to Patients With Metastatic Colorectal Cancer

OBJECTIVES: I. Assess the antitumor activity of 6-hydroxymethylacylfulvene (MGI-114) when
given daily for 5 days every 28 days to patients with metastatic adenocarcinoma of the colon
or rectum. II. Evaluate the qualitative and quantitative toxicities of MGI-114 given on this
schedule in this patient population.

OUTLINE: Patients receive 6-hydroxymethylacylfulvene (MGI-114) IV over 5 minutes daily for 5
consecutive days. Courses are repeated every 28 days. The minimum treatment period is 2
courses. Treatment continues indefinitely in the absence of unacceptable toxic effects or
disease progression. Patients are followed at the end of every other course while on the
study, and then every 3 months thereafter until death.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 6-10

Inclusion Criteria

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor Activity of MGI-114

Outcome Time Frame:

Every 28 day cycle

Safety Issue:


Principal Investigator

Paulo Hoff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1998

Completion Date:

November 2000

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • 6-hydroxymethylacylfulvene
  • MGI-114
  • Irofulven
  • Colorectal Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009