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Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2) (STOP)

This study has been terminated.
(Terminated due to poor accrual)
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00638963
First received: January 10, 2008
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to determine whether temozolomide can be used as a prophylaxis against brain recurrence in participants with metastatic breast cancer.


Condition Intervention Phase
Breast Neoplasm
Brain Neoplasm
Second Neoplasm
 Drug: temozolomide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Percent of Participants With Recurrence of Brain Metastases [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    The analysis could not be performed due to low enrollment.


Secondary Outcome Measures:
  • Number of Days With Progression-free Survival (PFS) [ Time Frame: 24, 38, and 52 weeks ] [ Designated as safety issue: No ]

    PFS was defined as the time interval from randomization to objective tumor progression or death from any cause.

    The analysis could not be performed due to low enrollment.


  • Number of Days With Disease-free Survival (DFS) [ Time Frame: 24, 38, and 52 weeks ] [ Designated as safety issue: No ]

    DFS was defined as the time interval from randomization to any relapse (loco-regional, contra-lateral, and/or distant).

    The analysis could not be performed due to low enrollment.


  • Number of Days With Distant Disease-free Survival (DDFS) [ Time Frame: 24, 38, and 52 weeks ] [ Designated as safety issue: No ]

    DDFS was defined as the time interval from randomization to only distant metastases (for example, bone, visceral organ, brain).

    The analysis could not be performed due to low enrollment.


  • Number of Days With Brain Recurrence-free Survival (BRFS) [ Time Frame: 24,38, and 52 weeks ] [ Designated as safety issue: No ]

    BRFS was defined as the time interval from randomization to the appearance of brain metastases.

    The analysis could not be performed due to low enrollment.


  • Number of Days on Temozolomide Treatment [ Time Frame: Baseline to 24 Weeks ] [ Designated as safety issue: No ]
    This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

  • Total Dose of Temozolomide Taken [ Time Frame: Baseline to 24 Weeks ] [ Designated as safety issue: No ]
    This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

  • Number of Participants Who Had at Least One Dose Reduction During Treatment [ Time Frame: Baseline to 24 Weeks ] [ Designated as safety issue: No ]
    This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

  • Number of Participants Who Had at Least One Treatment Omission During Treatment [ Time Frame: Baseline to 24 Weeks ] [ Designated as safety issue: No ]
    This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

  • Number of Participants Who Completed the Third Cycle of Treatment [ Time Frame: Baseline to 24 Weeks ] [ Designated as safety issue: No ]
    This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.


Enrollment: 6
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temozolomide Drug: temozolomide
Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
No Intervention: Observational

Detailed Description:

Breast cancer is the second most common cause of brain metastases. Overall survival after the development of brain metastases tends to be poor (6-8 months). Over-expression of Human Epidermal Growth Factor Receptor 2 (HER-2/neu), negative estrogen receptor, and young age at diagnosis seem to be indicators of high risk for brain metastases. Temozolomide may be a good candidate for prophylactic chemotherapy because of its ability to cross the blood-brain-barrier, achieving high concentrations in the central nervous system (CNS).

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of metastatic breast cancer.
  • Participants must have completed first line of metastatic chemotherapy and have achieved complete or partial response or disease stability for at least 6 months from the first confirmation of disease stabilization.
  • No clinical sign of brain progression.
  • At least one of the following 3 conditions: HER2 +++, Young age (< 50 years), and/or estrogen receptor (ER)-/progesterone receptor (PgR)-
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Life expectancy ≥3 months.
  • Neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL, lymphocytes ≥1 x 10^9/L.
  • Bilirubin level either normal or <1.5 x ULN (upper limit of normal).
  • AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤2.5 x ULN (≤5 x ULN if liver metastases are present).
  • Serum creatine <1.5 x ULN.
  • Effective contraception if the risk of conception exists.

Exclusion Criteria:

  • Concurrent chronic systemic immune therapy not indicated in the study protocol.
  • Any investigational agent(s) within 4 weeks prior to entry.
  • Participants that have completed 2nd, 3rd, or 4th line metastatic chemotherapy or participant in active chemotherapy treatment.
  • Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months.
  • Acute or sub acute intestinal occlusion or history of inflammatory bowel disease.
  • Known Grade 3 or Grade 4 allergic reaction to any of the components of the treatment.
  • Known drug abuse/alcohol abuse.
  • Legal incapacity or limited legal capacity.
  • Medical or psychological condition which in the opinion of the investigator would not permit the participant to complete the study or sign meaningful informed consent.
  • Women who are pregnant or breastfeeding.
  • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (participants with a previous malignancy but without evidence of disease for ≥5 years will be allowed to enter the trial).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00638963     History of Changes
Other Study ID Numbers: P05225, 2007-005491-14
Study First Received: January 10, 2008
Results First Received: June 23, 2011
Last Updated: June 23, 2011
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Brain Neoplasms
Breast Neoplasms
Neoplasms
Recurrence
Neoplasms, Second Primary
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Breast Diseases
 Skin Diseases
Disease Attributes
Pathologic Processes
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013