Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Chemotherapy

NCT ID: NCT00070031

Last Updated: 2013-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2009-12-31

Brief Summary

RATIONALE: Drugs used in chemotherapy such as edotecarin use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well edotecarin works in treating women with locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.

Detailed Description

OBJECTIVES:

Primary

• Determine the antitumor activity of edotecarin in women with anthracycline- and taxane-refractory or chemoresistant locally advanced or metastatic breast cancer.

Secondary

• Determine the time to tumor response and duration of response in patients treated with this drug.
• Determine the overall survival of patients treated with this drug.
• Determine the clinical benefit of this drug in these patients.
• Determine the safety and tolerability of this drug in these patients.
• Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive edotecarin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months until disease progression.

PROJECTED ACCRUAL: A total of 31-65 patients will be accrued for this study.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

edotecarin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary adenocarcinoma of the breast

• Locally advanced or metastatic disease
• Not amenable to surgery or radiotherapy with curative intent
• At least 1 unidimensionally measurable lesion

• At least 20 mm by conventional techniques OR 10 mm by CT scan
• Not previously irradiated
• Meets 1 of the following criteria:

• Previously treated with anthracycline and concurrent or sequential taxane therapy

• Refractory to the most recent taxane-based chemotherapy, defined as 1 of the following:

• Progressive disease during therapy or within 4 months of the last dose with or without documented response for advanced disease
• Progressive disease within 6 months of completing taxane-based chemotherapy as neoadjuvant therapy
• Resistant to prior chemotherapy, as defined by progressive disease within 6 months of completing prior chemotherapy for advanced disease
• No known brain metastases or carcinomatous meningitis* NOTE: *Baseline CT scan or MRI of the brain required if there is clinical suspicion of CNS metastases
• No spinal cord compression
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9.0 g/dL

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN (5 times ULN if liver involvement secondary to tumor is present)
• Albumin at least 3.0 g/dL

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• LVEF at least 50% or ULN by echocardiogram or MUGA
• None of the following within the past 6 months:

• Myocardial infarction
• Severe or unstable angina
• Symptomatic congestive heart failure
• Cerebrovascular accident or transient ischemic attack
• Deep vein thrombosis or other significant thromboembolic event
• No ongoing cardiac dysrhythmias grade 2 or greater
• No atrial fibrillation of any grade

Pulmonary

• No pulmonary embolism within the past 6 months

Gastrointestinal

• No active inflammatory bowel disease
• No partial or complete bowel obstruction
• No chronic diarrhea

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No known HIV positivity
• No active infection
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or confound study results

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent biological response modifiers
• No concurrent immunotherapy
• No concurrent sargramostim (GM-CSF)
• No other concurrent granulocyte colony-stimulating factors

Chemotherapy

• See Disease Characteristics
• Prior adjuvant chemotherapy allowed
• No prior topoisomerase I inhibitors
• No more than 2 prior chemotherapy regimens for advanced disease
• No prior high-dose chemotherapy that required hematopoietic stem cell rescue
• No other concurrent chemotherapy

Endocrine therapy

• Prior adjuvant hormonal therapy or hormonal therapy for advanced/metastatic disease allowed provided that therapy is discontinued before study entry
• No concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics
• No prior radiotherapy to more than 25% of the bone marrow
• No concurrent radiotherapy during and for 5 days after study treatment

• Palliative radiotherapy allowed provided no more than 20% of the bone marrow is involved

Surgery

• No coronary/peripheral artery bypass graft within the past 6 months

Other

• Recovered from prior therapy (except alopecia or neurotoxicity)
• At least 4 weeks since any other prior therapy
• More than 4 weeks since prior investigational agents
• No concurrent enrollment on another clinical trial
• No other concurrent approved or investigational anticancer treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Andrew D. Seidman, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Clifford A. Hudis, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-03056

Identifier Type: -

Identifier Source: secondary_id

PHARMACIA-EDOABC-4439-001

Identifier Type: -

Identifier Source: secondary_id

CDR0000329917

Identifier Type: -

Identifier Source: org_study_id