Clinical trial NCT00070031 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: edotecarin
SMILES: OCC(CO)NN1C(=O)C2=C3C(NC4=C3C=CC(O)=C4)=C3N([C@@H]4O[C@H](CO)[C@@H](O)[C@H](O)[C@H]4O)C4=C(C=CC(O)=C4)C3=C2C1=O
Eligibility 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

        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