Irofulven in Treating Patients With Metastatic Colorectal Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: Irofulven (MGI-114) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of MGI-114 (NSC# 683863) Administered Intravenously for Five Days Every 28 Days to Patients With Metastatic Colorectal Cancer |
- Antitumor Activity of MGI-114 [ Time Frame: Every 28 day cycle ] [ Designated as safety issue: No ]
| Enrollment: | 26 |
| Study Start Date: | August 1998 |
| Study Completion Date: | November 2000 |
| Primary Completion Date: | November 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Irofulven
6-hydroxymethylacylfulvene (MGI-114) IV over 5 minutes daily for 5 consecutive days every 28 day cycle.
|
Drug: Irofulven (MGI-114)
IV over 5 minutes daily for 5 consecutive days. Courses repeated every 28 days. Minimum treatment period is 2 courses.
Other Names:
|
Detailed Description:
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 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00003441
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Paulo Hoff, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003441 History of Changes |
| Other Study ID Numbers: | DM97-308, P30CA016672, U01CA070172, MDA-DM-97308, NCI-T97-0113, CDR0000066469 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by M.D. Anderson Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site |
Rectal Diseases Irofulven Alkylating Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015