Irofulven in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00003786
• Other study ID #: 9635
• Secondary ID: UCCRC-9635NCI-T9
• Status: Withdrawn
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: March 6, 2014
• Start date: April 1999
• Est. completion date: November 2000

Study information

• Verified date: March 2014
• Source: University of Chicago
• 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: Phase II trial to study the effectiveness of irofulven in treating patients with metastatic or recurrent colorectal cancer.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2000
• Est. primary completion date: November 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• irofulven

Locations

Country	Name	City	State
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Cancer Care Specialists of Central Illinois, S.C.	Decatur	Illinois
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Illinois Oncology Research Association	Peoria	Illinois
United States	Michiana Hematology/Oncology P.C.	South Bend	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response Rate		3 years	No