Pemetrexed-Carboplatin and Gemcitabine-Vinorelbine in Advanced Breast Cancer
The primary purpose of this study is to help answer the following research questions:
- whether the chemotherapy combination therapy Pemetrexed-Carboplatin or Gemcitabine-Vinorelbine can help participants with advanced breast cancer to make the tumor smaller or disappear and for how long
- to learn more about the side effects in each chemotherapy combination treatment arm
- to assess how participants with advanced breast cancer report health changes while receiving any of the chemotherapy combination arm
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study of Two Chemotherapy Regimens, Pemetrexed-Carboplatin, and Gemcitabine-Vinorelbine, in Anthracycline and Taxanes Pretreated Advanced Breast Cancer Patients|
- Tumor Response Rate [ Time Frame: Baseline up to 30 days of follow-up after 21 cycles of treatment ] [ Designated as safety issue: No ]Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants*100.
- Duration of Response (DOR) [ Time Frame: Time of response to progressive disease (up to 19 months) ] [ Designated as safety issue: No ]DOR-RECIST criteria of (Complete Response [CR =Disappearance of lesions] or Partial Response [PR=≥30% size decrease of lesions]) is defined as time from the date when measurement criteria are met for CR or PR until the date of first observation of progressive disease (PD) or death from study disease. For participants who die from causes other than study disease and without PD, DOR will be censored at the date of death. For participants who have not died as of the data cut-off date who are without PD, DOR was censored at last contact date.
- Time to Progressive Disease (PD) [ Time Frame: Baseline to measured PD (up to 25.1 months) ] [ Designated as safety issue: No ]Time to PD is defined as the time from the date of study enrollment to the first documented date of PD or death from study disease. For participants who die from causes other than study disease and without PD, time to PD was censored at the date of death. For participants not known to have died as of the data cut-off date and do not have PD, time to PD was censored at the last contact date. For participants who received subsequent chemotherapy (after discontinuation from the study chemotherapy) prior to disease progression, time to PD was censored at the date of subsequent chemotherapy.
- Time To Treatment Failure (TTTF) [ Time Frame: Baseline to end of treatment (up to 21.9 months) ] [ Designated as safety issue: No ]TTTF is defined as the time from date of study enrollment to the first documented date of death, PD, or study treatment discontinuation due to adverse event (AE). For participants not known to have discontinued as of the data cut-off date, TTTF is censored at the last contact date. For participants who discontinued for reasons other than death, PD, or AE, TTTF is censored at the date of discontinuation.
- Time to Response [ Time Frame: Baseline to response (up to 7.8 months) ] [ Designated as safety issue: No ]Time to response (Complete Response(CR) or Partial Response (PR) is defined as the time from the date of study enrollment to the first date when the measurement criteria are met for complete response or partial response (whichever status is recorded first). CR=Disappearance of target lesions lesions. PR=≥30% size decrease of lesions.
- Number of Participants With Adverse Events (AE) [ Time Frame: every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up) ] [ Designated as safety issue: Yes ]A listing of adverse events is presented in the Reported Adverse Event Module.
|Study Start Date:||June 2006|
|Study Completion Date:||August 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1.
Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC (Area under the plasma drug concentration versus time curve) 5.0 mg*min/mL. The cycle of treatment was 21 days.
600 mg/m^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity.
Other Names:Drug: Carboplatin
AUC 5 mg*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity.
Active Comparator: Gemcitabine/Vinorelbine
Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
1200 mg/m^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
Other Names:Drug: Vinorelbine
30 mg/m^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325234
|Guetersloh, Germany, 33332|
|Hamburg, Germany, 22081|
|Stuttgart, Germany, 70190|
|Bergamo, Italy, 24128|
|Bologna, Italy, 40139|
|Livorno, Italy, 57128|
|Meldola, Italy, 47014|
|Rome, Italy, 00168|
|San Giovanni Rotondo, Italy, 71013|
|Durban, South Africa, 4067|
|Morningside, South Africa, 2199|
|Pretoria, South Africa, 0001|
|Barcelona, Spain, 08036|
|Girona, Spain, 17007|
|La Coruña, Spain, 15006|
|Lleida, Spain, 25198|
|Madrid, Spain, 28040|
|Valencia, Spain, 46010|
|Zaragoza, Spain, 50009|
|Besevler/Ankara, Turkey, 06500|
|Bornova, Turkey, 35100|
|Kayseri, Turkey, 38039|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|