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

NCT00005822 | Completed Phase 1 DMC

• 5 other identifiers: CWRU5199U01CA062502P30CA043703CWRU-5199NCI-T99-0099
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; stage IIIB breast cancer; inflammatory breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

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

  Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.

Interventions

doxorubicin hydrochloride DRUG

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.

semaxanib DRUG

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.

Also known as: SU5416

conventional surgery PROCEDURE

Patients undergo a modified radical mastectomy.

radiation therapy RADIATION

Patients undergo radiotherapy to the chest wall and regional lymph nodes.

tamoxifen DRUG

Patients with estrogen or progesterone receptor positive disease receive oral tamoxifen for 5 years after radiotherapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms; Breast Neoplasms, Male

Interventions

Doxorubicin; Semaxinib; Radiotherapy; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Therapeutics; Stilbenes; Benzylidene Compounds; Benzene Derivatives

Study Officials

• Beth A. Overmoyer, MD, FACP

  Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: April 1, 2000
• Primary Completion: December 1, 2002
• Study Completion: October 1, 2003
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (1)