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Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer


Phase 2
N/A
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer


OBJECTIVES:

I. Evaluate the response rate and time to treatment failure in patients with refractory
metastatic adenocarcinoma of the breast treated with irofulven.

II. Assess the qualitative and quantitative toxic effects of this drug in these patients.

III. Determine the population pharmacokinetics and the pharmacokinetics-pharmacodynamic
relationships of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28
days in the absence of disease progression or unacceptable toxicity.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic adenocarcinoma of the breast

- Measurable disease outside previously irradiated area or occurred/progressed after
completion of radiotherapy

- Must have received 1 or 2 prior chemotherapy regimens for metastatic disease

- More than 3 prior regimens allowed

- No active brain metastases or meningeal breast cancer involvement

PATIENT CHARACTERISTICS:

Sex:

- Male or female

Performance status:

- SWOG 0-2

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 3 times ULN (5 times ULN for liver metastases)

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No history of myocardial infarction or unstable angina within the past 6 months

- No uncontrolled congestive heart failure

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Prior diagnosis of cancer allowed (must be off cancer therapy and have no evidence of
disease)

- No history of retinopathy and/or macular degeneration

PRIOR CONCURRENT THERAPY:

Chemotherapy:

- No prior irofulven

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Lisa Hammond, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas Health Science Center at San Antonio

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066939

NCT ID:

NCT00003796

Start Date:

May 1999

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • male breast cancer
  • Breast Neoplasms

Name

Location

University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811