A phase 2 study of ALIMTA plus doxorubicin administered every 21 days in patients with advanced breast cancer
- Conditions
- Advanced breast cancer
- Registration Number
- EUCTR2004-000691-13-ES
- Lead Sponsor
- illy S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 70
[1] Histologic or cytologic diagnosis of breast cancer with locally advanced or metastatic disease that is not amenable to local treatment (for example, surgery or radiotherapy).
[2] Patients must be chemonaive or have received only neoadjuvant and/or adjuvant chemotherapy.
[3] At least one unidimensionally measurable lesion, meeting Response Evaluation Criteria in Solid Tumors (RECIST; Therasse et al. 2000, see Protocol Attachment JMGV.3) criteria (at least 10 mm in longest diameter by spiral computed tomography [(CT]) scan, or at least 20 mm by standard techniques). Ultrasounds and positron emission tomography (PET) scans cannot be used.
[4] No chemotherapy is allowed within 4 weeks before enrollment in the study; prior therapy or concomitant therapy with bisphosphonates is allowed, per Section 5.7.7 of this document.
[5] Prior endocrine therapy is allowed but must be stopped at the time of enrollment, with the exception of luteinizing hormone-releasing hormone (LH-RH) analogues.
[6] Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale (Oken et al. 1982, see Protocol Attachment JMGV.1).
[7] Prior radiation therapy is allowed to <25% of the bone marrow (Cristy and Eckerman 1987), but must be stopped 2 weeks before enrollment in the study.
[8] Estimated life expectancy of at least 12 weeks.
[9] Patient compliance and geographic proximity that allow for adequate follow-up.
[10] Adequate organ function including the following:
- adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ³1.5 ´ 109/L, platelets ³100 ´ 109/L, and hemoglobin ³9.0 g/dL
- hepatic: bilirubin £1.5 ´ the upper limit of normal (ULN), alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) £3.0 ´ ULN (ALP, AST, and ALT £5.0 ´ ULN are acceptable if the liver has tumor involvement)
- renal: calculated creatinine clearance (CrCl) ³45 mL/min by using the standard Cockcroft and Gault formula (Cockcroft and Gault 1976, see Protocol Attachment JMGV.2) or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method (5-CrEDTA or Tc99m-DTPA).
[11] Signed informed consent from the patient or legal representative.
[12] Women at least 18 years of age.
[13] Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after treatment. Women of childbearing potential must have a negative serum pregnancy test and must not be lactating.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
[14] Prior chemotherapy for advanced breast cancer.
[15] Prior treatment with any anthracycline- or anthracenedione-containing regimen.
[16] Serious concomitant systemic disorders, including active infection, that would compromise the safety of the patient or compromise the patient’s ability to tolerate and/or complete the study, at the discretion of the investigator.
[17] Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of enrollment.
[18] Documented brain metastases (unless the patient has completed successful local therapy for central nervous system [CNS] metastases and has not taken corticosteroids for at least 4 weeks before enrollment). Brain imaging is not required in asymptomatic patients, but is required in symptomatic patients to rule out brain metastases.
[19] Second primary malignancy (except adequately treated in situ carcinoma of the cervix, adequately treated nonmelanomatous carcinoma of the skin, or other malignancy treated at least 5 years previously with no evidence of recurrence).
[20] Significant cardiovascular disease in the form of abnormal electrocardiogram (ECG) or clinical features of recent or recurrent cardiac disease (including myocardial infarction, angina, hypertensive cardiomyopathy, or left ventricular ejection fraction [LVEF] to below the lower limit of normal or an absolute LVEF £45%).
[21] Pregnancy and/or breast-feeding.
[22] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents (NSAIDs) 2 days before, the day of, and 2 days after the dose of ALIMTA (5 days prior for long-acting agents such as piroxicam).
[23] Persons who have previously completed or withdrawn from this study or any other study investigating ALIMTA.
[24] Inability or unwillingness to take folic acid, vitamin B12, or dexamethasone supplementation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method