A randomised Phase II study of two chemotherapy regimens, Pemetrexed-Carboplatin, and Gemcitabine-vinorelbine, in Anthracycline and Taxane pretreated Advanced Breast cancer patients.

Eli lilly and Company Limited0 sites144 target enrollmentFebruary 24, 2006

Conditionsadvanced breast cancer MedDRA version: 8.0Level: LLTClassification code 10006285

DrugsAlimta 500 mg Carboplatin 10 mg/ml Intravenous Infusion (50 mg in 5 ml)Gemzar 200mg Navelbine 10mg/ml (10 mg in 1 ml)Carboplatin 10 mg/ml Intravenous Infusion (150 mg in 15 ml)Gemzar 1g Navelbine 10mg/ml (50 mg in 5 ml)Neocorp 50mg/5ml

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: advanced breast cancer
Sponsor: Eli lilly and Company Limited
Enrollment: 144
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 24, 2006

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Eli lilly and Company Limited

Eligibility Criteria

Inclusion Criteria

•\[1]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.
•\[2]Performance status of 0 to 2 on the ECOG performance status schedule. See Protocol Attachment S098\.2\.
•\[3]One prior chemotherapy containing anthracyclines as (neo)adjuvant or palliative 1st\-line treatment.
•\[4]One prior chemotherapy containing taxanes as (neo)adjuvant or palliative 1st\-line treatment.
•\[5]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.
•\[6]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
•\[7]Antitumoral hormonal treatment must be discontinued prior to enrollment.
•\[8]Estimated life expectancy of at least 3 months.
•\[9]Patient compliance and geographic proximity that allow adequate follow\-up.
•\[10]Adequate organ function including the following:

Exclusion Criteria

•\[14]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.
•\[15]Have previously completed or withdrawn from this study or any other study investigating Pemetrexed, Gemcitabine, Carboplatin or Vinorelbine
•\[16]Have received more than one line of chemotherapy in MBC. Patients having received more than one combination of A plus T.
•\[17]Are pregnant or breast\-feeding.
•\[18]Have serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study.
•\[19]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.
•\[20]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 \= 80 ml/min.
•\[21]Have central nervous system (CNS) metastases.
•\[22]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.
•\[23]Are unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.