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SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
This study has been completed.
First Received: June 2, 2000   Last Updated: March 5, 2009   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005822
  Purpose

RATIONALE: SU5416 may stop the growth of breast cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combining SU5416 and doxorubicin in treating patients who have stage IIIB or stage IV inflammatory breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: doxorubicin hydrochloride
Drug: semaxanib
Procedure: conventional surgery
Radiation: radiation therapy
Phase I

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Semaxanib SU 5416
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Pharmacokinetic, Pharmacodynamic, and Clinical Study of the Combination of the Angiogenesis Inhibitor SU5416 and Doxorubicin in Inflammatory Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2000
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of SU5416 and doxorubicin in patients with stage IIIB or IV inflammatory breast cancer.
  • Determine the overall response, response rate, and progression-free survival rate of patients treated with this regimen.
  • Determine the antiangiogenic effects of this regimen in these patients.
  • Assess the relationship of plasma levels of these drugs with safety and efficacy in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive doxorubicin IV continuously over 72 hours on days 1-3 of course 1. For all subsequent courses, patients receive doxorubicin as in course

1 and SU5416 IV over 1 hour twice weekly (on days 1 and 4) beginning on week 2 of course 2. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity. After chemotherapy, all patients undergo a modified radical mastectomy and radiotherapy to the chest wall and regional lymph nodes. Patients with estrogen or progesterone receptor positive disease receive oral tamoxifen for 5 years after radiotherapy.

Cohorts of 3-6 patients receive escalating doses of SU5416 and doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 3 patients may be treated at that dose level.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-9 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage IIIB or IV (supraclavicular lymph node involvement or metastasis) inflammatory breast cancer

    • Primary or secondary
  • No brain metastases or primary brain tumors
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • WBC at least 3,500/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 9.0 g/dL

Hepatic:

  • Bilirubin normal
  • AST and ALT less than 2 times upper limit of normal
  • PT and PTT normal OR
  • INR less than 1.1

Renal:

  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • LVEF at least 50% by MUGA
  • No New York Heart Association class III or IV heart disease
  • No uncompensated coronary artery disease
  • No myocardial infarction or unstable angina within the past 6 months
  • No deep venous or arterial thrombosis within the past 3 months

Pulmonary:

  • No history of pulmonary embolism within the past 3 months

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of diabetes mellitus with severe peripheral vascular disease
  • No other prior or concurrent malignancies within the past 10 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • No other uncontrolled illnesses

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent epoetin alfa or filgrastim (G-CSF)

Chemotherapy:

  • No more than 2 prior chemotherapy regimens allowed
  • No prior doxorubicin or other anthracycline

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior radiotherapy allowed

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005822

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Beth A. Overmoyer, MD, FACP Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067829, CWRU-5199, NCI-T99-0099
Study First Received: June 2, 2000
Last Updated: March 5, 2009
ClinicalTrials.gov Identifier: NCT00005822     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
stage IIIB breast cancer
inflammatory breast cancer
male breast cancer

Study placed in the following topic categories:
Anti-Bacterial Agents
Inflammatory Breast Cancer
Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms
Breast Cancer, Male
Angiogenesis Inhibitors
SU 5416
Doxorubicin
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses
Breast Neoplasms
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009