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

Breast Cancer Clinical Trial

Official title:

A Phase II Study of Intravenous Edotecarin (PHA-782615) in Patients With Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00070031
• Other study ID #: CDR0000329917
• Secondary ID: MSKCC-03056PHARM
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2003
• Last updated: December 18, 2013
• Start date: June 2003
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• edotecarin

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,