SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
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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 Drug: tamoxifen |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 |
- 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. ] [ Designated as safety issue: Yes ]
| Enrollment: | 21 |
| Study Start Date: | April 2000 |
| Study Completion Date: | October 2003 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
-
Drug: doxorubicin hydrochloride
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 |
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| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Study Chair: | Beth A. Overmoyer, MD, FACP | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Beth A. Overmoyer, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00005822 History of Changes |
| Other Study ID Numbers: | CWRU5199, U01CA062502, P30CA043703, CWRU-5199, NCI-T99-0099 |
| Study First Received: | June 2, 2000 |
| Last Updated: | June 10, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
stage IV breast cancer recurrent breast cancer stage IIIB breast cancer inflammatory breast cancer male breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Inflammatory Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Doxorubicin SU 5416 Tamoxifen Angiogenesis Inhibitors Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Antineoplastic Agents, Hormonal Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013