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SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
doxorubicin hydrochloride
semaxanib
conventional surgery
radiation therapy
tamoxifen
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer, inflammatory breast cancer, male breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ireland Cancer Center at University Hospitals Case Medical Center

Outcomes

Primary Outcome Measures

Determine the maximum tolerated dose of SU5416 and doxorubicin in patients with stage IIIB or IV inflammatory breast cancer.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
June 10, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005822
Brief Title
SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
Official Title
A Phase I Pharmacokinetic, Pharmacodynamic, and Clinical Study of the Combination of the Angiogenesis Inhibitor SU5416 and Doxorubicin in Inflammatory Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer, inflammatory breast cancer, male breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Description
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. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
semaxanib
Other Intervention Name(s)
SU5416
Intervention Description
For all subsequent courses, after course 1 patients 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.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
Patients undergo a modified radical mastectomy.
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
Patients undergo radiotherapy to the chest wall and regional lymph nodes.
Intervention Type
Drug
Intervention Name(s)
tamoxifen
Intervention Description
Patients with estrogen or progesterone receptor positive disease receive oral tamoxifen for 5 years after radiotherapy.
Primary Outcome Measure Information:
Title
Determine the maximum tolerated dose of SU5416 and doxorubicin in patients with stage IIIB or IV inflammatory breast cancer.
Time Frame
Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth A. Overmoyer, MD, FACP
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer

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