Clinical trial NCT00003786: Irofulven in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Official title: A Phase II Trial of MGI-114 (NSC# 683863) Administered as a 5-Minute Infusion Daily for Five Days Every 4 Weeks in Patients With Previously Untreated Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: 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
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-08-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 or recurrent colorectal cancer.

Detailed description: OBJECTIVES: I. Determine the objective response rate of patients with metastatic or locally recurrent adenocarcinoma of the colon or rectum treated with 6-hydroxymethylacylfulvene (MGI-114). II. Determine the toxicity of this treatment regimen in this patient population. III. Study pharmacokinetics of MGI-114 in these patients. IV. Determine the relationship between pharmacokinetics of MGI-114 and clinical outcomes including toxicity and response to therapy in these patients.

OUTLINE: This is an open label, multicenter study. Patients receive 6-hyroxymethylacylfulvene (MGI-114) IV over 5 minutes daily for 5 days. Courses are repeated every 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxic effects or disease progression. Patients are followed until death.

PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study within 6-12 months.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed metastatic or locally recurrent adenocarcinoma of the colon or rectum Bidimensionally measurable disease Lesions seen on colonoscopic examination or barium studies, bone metastases, CNS lesions, CEA levels and ascites are not considered measurable No CNS disease only CNS metastases with other sites of measurable disease allowed provided appropriate therapy for CNS metastases has been administered and patient is neurologically stable and does not require intravenous steroid or anticonvulsant therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 (no platelet transfusion within 7 days) Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant uncontrolled medical or psychiatric illness No serious active infection No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless adequately treated and less than 30% risk of relapse

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic use of growth factors except for documented febrile neutropenia or sepsis Chemotherapy: At least 12 months since prior fluorouracil based adjuvant or neoadjuvant chemotherapy No more than 1 prior regimen No prior chemotherapy for advanced metastatic colorectal cancer No other concurrent chemotherapy No concurrent investigational antineoplastic drugs Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to the only site of measurable disease No concurrent radiotherapy Surgery: Not specified Other: See Disease Characteristics At least 30 days since prior investigational drug

Primary outcomes:
measure: Clinical Response Rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Chicago
country: United States
facility: Louis A. Weiss Memorial Hospital
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Central Illinois, S.C.
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Cancer Care Center
state: Illinois
city: Peoria
country: United States
facility: Illinois Oncology Research Association
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology, Inc.
state: Indiana
city: South Bend
country: United States
facility: Michiana Hematology/Oncology P.C.
state: Indiana
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: University of Chicago
name: Hedy L. Kindler, MD
role: STUDY_CHAIR
References: