Paclitaxel Plus Monoclonal Antibody Therapy in Treating Women With Recurrent or Metastatic Breast Cancer

NCT00003539 | Completed Phase 2

• 3 other identifiers: 98-028CDR0000066593NCI-G98-1473
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus monoclonal antibody therapy in treating women with recurrent or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

trastuzumab BIOLOGICAL

paclitaxel DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic breast cancer Bidimensionally measurable disease No bone scan abnormalities alone Lytic lesions allowed in conjunction with bone scan abnormalities No pure blastic bone metastases No pleural or peritoneal effusions No previously irradiated lesions Resected disease not allowed No brain metastases or leptomeningeal disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1500/mm3 Hemoglobin at least 8.0 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL Calcium no greater than 11.0 mg/dL Cardiovascular: No history of arrhythmias No history of other significant cardiac diseases No New York Heart Association class III or IV cardiac function Left ventricular ejection fraction at least 50% Pulmonary: No symptomatic lymphangitic pulmonary metastases Other: Not pregnant Negative pregnancy test No history of other malignancy except: Carcinoma in situ of the cervix Curatively treated nonmelanoma skin cancer No severe infection No severe malnutrition No other serious medical illness No history of grade 3-4 peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No more than 3 prior chemotherapy regimens as adjuvant/neoadjuvant therapy or for disease At least 1 year since prior paclitaxel or docetaxel Prior anthracycline (doxorubicin or epirubicin) or mitoxantrone-based regimen allowed as adjuvant therapy or for advanced disease No other concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy Radiotherapy: No radiotherapy to greater than 50% of marrow At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherepy to the only measurable lesion Surgery: At least 2-3 weeks since prior surgery and recovered No concurrent surgery to the only measurable lesion Other: No concurrent nonprotocol treatment

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (3)

• Seidman AD, Fornier MN, Esteva FJ, Tan L, Kaptain S, Bach A, Panageas KS, Arroyo C, Valero V, Currie V, Gilewski T, Theodoulou M, Moynahan ME, Moasser M, Sklarin N, Dickler M, D'Andrea G, Cristofanilli M, Rivera E, Hortobagyi GN, Norton L, Hudis CA. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol. 2001 May 15;19(10):2587-95. doi: 10.1200/JCO.2001.19.10.2587.

  PMID: 11352950 RESULT

• Seidman AD, Fornier M, Esteva F, et al.: Final report: weekly herceptin and taxol for metastatic breast cancer: analysis of efficacy by HER2 immunophenotype [immunohistochemistry (IHC)] and gene amplification [fluorescent in-situ hybridization (FISH)]. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A319, 2000.

  RESULT

• Fornier M, Seidman AD, Esteva FJ, et al.: Weekly herceptin plus one hour taxol: phase II study in HER2 overexpressing (H2+) and non-overexpressing (H2-) metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A482, 1999.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Andrew D. Seidman, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 4, 2004
• Study Start: April 1, 1998
• Primary Completion: February 1, 2003
• Study Completion: February 1, 2003
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

US (1)