Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01091454
First received: March 18, 2010
Last updated: March 24, 2012
Last verified: March 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving brostallicin together with cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving brostallicin together with cisplatin works in treating patients with metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: brostallicin
Drug: cisplatin
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Brostallicin and Cisplatin in Patients With Metastatic Triple Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 3-month progression-free survival (PFS) rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Confirmed response rate (complete or partial response) [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • 6-month PFS rate [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Survival time [ Designated as safety issue: No ]
  • Glutathione/glutathione levels measured at baseline and at 22-26 hours after cisplatin administration (before brostallicin administration) [ Designated as safety issue: No ]
  • Correlation of increased glutathione/glutathione levels and primary and secondary endpoints [ Designated as safety issue: No ]
  • Correlation of BRCA1 mutation and 3-month PFS [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: July 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To identify any clinical efficacy of treatment with brostallicin and cisplatin, as measured by progression-free survival (PFS) at 3 months, in patients with triple-negative metastatic breast cancer.

Secondary

  • To describe the confirmed tumor response rate in these patients.
  • To describe the duration of response in these patients.
  • To describe the 6-month PFS of these patients.
  • To describe the overall survival of these patients.
  • To evaluate the adverse event profile of this regimen according to the current version of NCI CTCAE.

Tertiary

  • To assess the baseline glutathione levels in whole blood (before the administration of cisplatin) in these patients and to correlate those levels with the primary and secondary endpoints. (Translational research)
  • To evaluate whether cisplatin administered the day before the administration of brostallicin leads to an increased level of glutathione/glutathione S-transferase levels in vivo and whether such increase is associated with improvement of the primary and secondary endpoints. (Translational research)
  • To assess the prevalence of BCRA-1 mutation by IHC on the primary or metastatic tumor in these patients. (Translational research)
  • To assess the association of BRCA-1 mutation by IHC with the primary and secondary endpoints. (Translational research)
  • To bank paraffin-embedded tissue blocks or slides and blood products for future studies as part of ongoing research for NCCTG breast studies. (Translational research)

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for translational research studies. Tumor tissue samples may also be collected for research studies.

After completion of study therapy, patients are followed up every 3 months until disease progression and then every 6 months for up to 5 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the breast

    • Clinical evidence of metastatic disease
  • Measurable disease according to RECIST criteria
  • Triple-negative breast cancer, defined as the following:

    • HER2-negative (according to active ASCO/CAP guidelines)
    • Estrogen receptor- and progesterone receptor-negative tumor defined as ≤ 1% by IHC
  • No evidence of active brain metastasis including leptomeningeal involvement

    • CNS metastasis allowed provided it is controlled after prior surgery and/or radiotherapy, as defined by the following criteria:

      • No symptoms for ≥ 2 months
      • No evidence of progression before study entry
      • Corticosteroid therapy to control brain edema has been discontinued

PATIENT CHARACTERISTICS:

  • Any menopausal status allowed
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT ≤ 3 times ULN (≤ 5 times ULN if the elevation is due to liver metastases)
  • Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if the elevations are due to liver metastases)
  • Serum creatinine ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study treatment
  • Willing to return to NCCTG enrolling institution for treatment and follow-up
  • Willing to provide blood samples for research purposes
  • No other stage III or IV invasive malignancy within the past 5 years
  • No pre-existing peripheral neuropathy ≥ grade 2 (according to the active version of NCI CTCAE criteria)
  • No active, unresolved infection
  • No clinically significant cardiovascular or cerebrovascular disease within the past 6 months, including any of the following:

    • Myocardial infarction
    • Unstable angina
    • NYHA class II-IV congestive heart failure
    • Uncontrolled or clinically significant cardiac arrhythmia (patients with controlled atrial fibrillation are eligible)
  • Not immunocompromised (unless related to the use of corticosteroids), including known HIV-positivity with an AIDS-defining illness

    • HIV-positive patients whose CD4 count is normal and who have no history of an AIDS-defining illness are eligible
  • No concurrent uncontrolled illness including, but not limited to, psychiatric illness or social situation, co-morbid systemic illness, or other severe concurrent disease that, in the judgement of the investigator, would make the patient inappropriate for study entry, would interfere significantly with the proper assessment of safety of the prescribed treatment, would limit compliance with study requirements, or would make it undesirable for the patient to participate in the study
  • No history of allergy or hypersensitivity to the study drugs or to their excipients, including platinum compounds (e.g., cisplatin, carboplatin)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 4 prior chemotherapy regimens in the metastatic setting
  • More than 4 weeks since prior major surgery
  • More than 3 weeks since prior chemotherapy or immunologic therapy
  • More than 2 weeks since prior radiotherapy (except for radiotherapy to a non-target lesion) and recovered (acute adverse events ≤ grade 1 according to the current version of NCI CTCAE)

    • Prior radiotherapy to a target lesion allowed provided there has been clear progression of the lesion since radiotherapy was completed
    • Patients who receive a single dose of radiotherapy for palliation or radiotherapy to a non-target lesion may proceed to study registration without waiting 2 weeks
  • No concurrent treatment in another clinical study in which investigational procedures are performed or investigational therapies are administered

    • Patients may not enroll in such clinical trials while participating in this study
    • Exception may be granted for trials related to symptom management (cancer control) that do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study
  • No other concurrent chemotherapeutic agents, biologic agents, or radiotherapy
  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: NCT01091454

  Show 266 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Alvaro Moreno Aspitia, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Joseph L. Pater, Cancer Research Institute at Queen's University
ClinicalTrials.gov Identifier: NCT01091454     History of Changes
Other Study ID Numbers: CDR0000665441, NCCTG-N0937
Study First Received: March 18, 2010
Last Updated: March 24, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
triple-negative breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014