A Randomized Phase II Study of two chemotherapy regimens, Pemetrexed-Carboplatin, and Gemcitabine-Vinorelbine, in Anthracycline and Taxane Pretreated Advanced Breast Cancer Patients - ND
- Conditions
- Women with histologic or cytologic diagnosis of advanced breast cancer, who have received one prior chemotherapy containing anthracyclines as neo adjuvant or palliative 1st-line treatment and one prior chemotherapy containing taxanes as neo adjuvant or palliative 1st-line treatment.MedDRA version: 8.1Level: LLTClassification code 10055113Term: Breast cancer metastatic
- Registration Number
- EUCTR2006-000441-19-IT
- Lead Sponsor
- ELI LILLY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 160
-Females with histologic or cytologic diagnosis of advanced breast cancer. See Protocol Attachment S098.1, American Joint Committee on Cancer Staging Criteria for Breast Cancer Fleming et al. 1997 . Lesions should not be amenable to surgery or radiation of curative intent. -Performance status of 0 to 2 on the ECOG performance status schedule. -One prior chemotherapy containing anthracyclines as neo adjuvant or palliative 1st-line treatment. -One prior chemotherapy containing taxanes as neo adjuvant or palliative 1st-line treatment. -Prior radiation therapy is allowed to 25 of the bone marrow Cristy and Eckerman, 1987 . Patients must have recovered from the toxic effects of the treatment prior to study enrollment except for alopecia . Prior radiotherapy must be completed 30 days before study entry. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy. -At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors RECIST; Therasse et al 2000 at least 10 mm in longest diameter by spiral computerized tomography CT scan, or at least 20 mm by standard techniques. Positron emission tomography PET scans and ultrasounds may not be used -Antitumoral hormonal treatment must be discontinued prior to enrollment. -Adequate organ function including the following Adequate bone marrow reserve absolute neutrophil segmented and bands count ANC up or equal to 1.5 x 10 9/L, platelets up or equal to 100 x 10 9/L, and hemoglobin up or equal to 9.0 g/dL.Hepatic bilirubin lower or equal to 1.5 times the upper limit of normal lower or equal to ULN , alkaline phosphatase AP , aspartate transaminase AST and alanine transaminase ALT lower or equal to3.0 x ULN AP, AST, and ALT lower or equal to5 x ULN is acceptable if liver has tumor involvement . Renal calculated creatinine clearance CrCl up or equal to 45 mL/min based on the standard Cockcroft and Gault formula see Protocol Attachment S098.3 . Enrollment and dosing decisions based on creatinine clearance will be made using local lab values. The same lab must be used throughout the study for dosing decisions. -Patients must sign an informed consent document. -Female patients at least 18 years of age.
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
-Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. -Have previously completed or withdrawn from this study or any other study investigating Pemetrexed, Gemcitabine, Carboplatin or Vinorelbine -Have received more than one line of chemotherapy in MBC. Patients having received more than one combination of A plus T. -Have a prior malignancy other than breast cancer, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. -Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period 8-day period for long-acting agents such as piroxicam , unless the Creatinine Clearance is up or equal to 80 ml/min. -Have central nervous system CNS metastases. -Have clinically relevant by physical exam third-space fluid collections for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. -Are unable or unwilling to take folic acid, vitamin B12 supplementation, or dexametasone. -Concurrent administration of any other antitumor therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to assess the antitumor activity, as measured by tumor response rate proportion of patients with complete or partial response for patients with advanced breast cancer who receive one of the two chemotherapy regimens Arm A Pemetrexed 600 mg/m2, D1 plus Carboplatin AUC 5, D1 combination therapy every 21 days Arm B Gemcitabine 1200 mg/m2 D1, D8 plus Vinorelbine 30 mg/m2 D1, D8 combination therapy every 21 days;Secondary Objective: The secondary objectives of the study are as follows to assess the time to event efficacy variables including 61485;duration of response 61485;time to response 61485;time to progressive disease 61485;time to treatment failure to characterize the quantitative and qualitative toxicities in each treatment arm in this patient population. To assess quality of life using the EORTC questionnaires QLQ-C30 and BR-23.;Primary end point(s): tumor response rate
- Secondary Outcome Measures
Name Time Method