Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	MSKCC-03056 PHARMACIA-EDOABC-4439-001, NCT00070031

Objectives

Primary

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

Secondary

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

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Andrew Seidman, MD, Principal investigator		Ph: 212-639-5875; 800-525-2225
Clifford Hudis, MD, Principal investigator		Ph: 646-888-4551; 800-525-2225

Registry Information
Official Title		A Phase II Study of Intravenous Edotecarin (PHA-782615) in Patients with Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer
Trial Start Date		2003-06-10
Registered in ClinicalTrials.gov		NCT00070031
Date Submitted to PDQ		2003-08-12
Information Last Verified		2005-05-05
NCI Grant/Contract Number		P30-CA08748

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