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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00070031
Recruitment Status : Completed
First Posted : October 7, 2003
Last Update Posted : December 19, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: edotecarin Phase 2

Detailed Description:



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


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Intravenous Edotecarin (PHA-782615) in Patients With Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer
Study Start Date : June 2003
Actual Primary Completion Date : April 2006
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


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


  • 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


  • Creatinine no greater than 1.5 mg/dL


  • 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


  • No pulmonary embolism within the past 6 months


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


  • 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


Biologic therapy

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


  • 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


  • 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


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00070031

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Andrew D. Seidman, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Clifford A. Hudis, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00070031    
Other Study ID Numbers: CDR0000329917
First Posted: October 7, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2009
Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases