Pemetrexed-Carboplatin and Gemcitabine-Vinorelbine in Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00325234
First received: May 10, 2006
Last updated: April 26, 2011
Last verified: April 2011
  Purpose

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

Condition Intervention Phase
Breast Cancer
Drug: Pemetrexed
Drug: Carboplatin
Drug: Gemcitabine
Drug: Vinorelbine
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 135
Study Start Date: June 2006
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed/Carboplatin

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.

Drug: Pemetrexed
600 mg/m^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity.
Other Names:
  • LY231514
  • Alimta
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.
Drug: Gemcitabine
1200 mg/m^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
Other Names:
  • LY188011
  • Gemzar
Drug: Vinorelbine
30 mg/m^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females with histologic or cytologic diagnosis of advanced breast cancer. Lesions should not be amenable to surgery or radiation of curative intent.
  • Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale.
  • 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 less than 25% of the bone marrow. Participants 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 uni-dimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Positron emission tomography [PET] scans and ultrasounds may not be used.
  • Antitumoral hormonal treatment must be discontinued prior to enrollment.
  • Estimated life expectancy of at least 3 months.
  • Participant compliance and geographic proximity that allow adequate follow-up.
  • Adequate organ function
  • Female participants of childbearing potential must test negative for pregnancy within 7 days of enrollment based on a urine and/or serum pregnancy test and agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
  • Participants must sign an informed consent document.
  • Female participants must be at least 18 years of age.

Exclusion Criteria:

  • 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 Metastatic Breast Cancer. Participants having received more than one combination of anthracycline plus taxane.
  • Are pregnant or breast-feeding.
  • Have serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to complete the study.
  • 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 greater than 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 dexamethasone.
  • Concurrent administration of any other antitumor therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325234

Locations
Germany
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Guetersloh, Germany, 33332
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Hamburg, Germany, 22081
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Stuttgart, Germany, 70190
Italy
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Bergamo, Italy, 24128
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Bologna, Italy, 40139
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Livorno, Italy, 57128
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Meldola, Italy, 47014
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Rome, Italy, 00168
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San Giovanni Rotondo, Italy, 71013
South Africa
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Durban, South Africa, 4067
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Morningside, South Africa, 2199
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Pretoria, South Africa, 0001
Spain
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Barcelona, Spain, 08036
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Girona, Spain, 17007
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La Coruña, Spain, 15006
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Lleida, Spain, 25198
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Madrid, Spain, 28040
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Valencia, Spain, 46010
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Zaragoza, Spain, 50009
Turkey
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Besevler/Ankara, Turkey, 06500
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Bornova, Turkey, 35100
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Kayseri, Turkey, 38039
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00325234     History of Changes
Other Study ID Numbers: 10826, H3E-EW-S098
Study First Received: May 10, 2006
Results First Received: April 26, 2011
Last Updated: April 26, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Turkey: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Pemetrexed
Vinorelbine
Vinblastine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Folic Acid Antagonists

ClinicalTrials.gov processed this record on July 31, 2014