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

NCT00070031 | Completed Phase 2

• 3 other identifiers: CDR0000329917MSKCC-03056PHARMACIA-EDOABC-4439-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Interventions

edotecarin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

edotecarin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrew D. Seidman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Clifford A. Hudis, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2003
• First Posted: October 7, 2003
• Study Start: June 1, 2003
• Primary Completion: April 1, 2006
• Study Completion: December 1, 2009
• Last Updated: December 19, 2013

Record last verified: 2009-12

Locations

US (1)