Chemotherapy in Treating Women With Metastatic Breast Cancer

NCT00004046 | Completed Phase 2

• 3 other identifiers: CDR0000067148DAIICHI-8951A-PRT011MDA-ID-98308
• Study Type: interventional
• Target: N/A
• 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. PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating women who have metastatic breast cancer that has not responded to previous therapy.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

exatecan mesylate DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the breast Prior treatment with an anthracycline (e.g., doxorubicin or epirubicin) and a taxane (e.g., paclitaxel or docetaxel) either as adjuvant therapy or for advanced disease Bidimensionally measurable disease Sentinel lesions must be outside of any prior radiation port No resected disease or stage IV with no evaluable disease No brain metastases or leptomeningeal disease No symptomatic lymphangitic pulmonary metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9.0 g/dL Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within past 6 months Neurologic: No history of an existing grade 3-4 peripheral neuropathy of any etiology Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No allergy to camptothecin or its derivatives No concurrent serious infection No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No overt psychosis, mental disability, or incompetence No other life threatening disease PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy No prophylactic colony stimulating factors to prevent neutropenia (except when neutropenia fever occurs despite dose reduction) Chemotherapy: See Disease Characteristics No greater than 3 prior chemotherapy regimens for metastatic breast cancer or as either adjuvant or neoadjuvant therapy At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No other concurrent cytotoxic chemotherapy Endocrine therapy: Exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy allowed At least 3 weeks since prior hormonal therapy except for: Patients who are highly unlikely to have a withdrawal response to cessation of hormonal therapy (e.g., patients with disease that is primarily resistant to hormonal therapy, patients without prior partial response, or stabilization of disease lasting less than 6 months) Patients with new or extensive visceral metastases Patients with rapidly progressive or symptomatic metastases during hormonal therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to greater than 50% of bone marrow No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered No concurrent surgery Other: No other concurrent anticancer treatment At least 28 days since other prior investigational drugs, including analgesics or antiemetics No other investigational drugs during and for 28 days after the study No drugs that induce or inhibit CYP3A enzyme

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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exatecan

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert L. DeJager, MD, FACP

  Daiichi Sankyo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: April 15, 2004
• Study Start: June 1, 1999
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

US (1)