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

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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



- 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.

Inclusion Criteria


- 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

- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Andrew D. Seidman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021