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A Phase II Study of Irinotecan and Temozolomide in Breast Cancer Patients With Brian Metastases That Have Progressed After Stereotactic Radiosurgery or Whole Brain Radiation


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Metastatic Cancer

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Trial Information

A Phase II Study of Irinotecan and Temozolomide in Breast Cancer Patients With Brian Metastases That Have Progressed After Stereotactic Radiosurgery or Whole Brain Radiation


OBJECTIVES:

Primary

- To evaluate the objective response rate systemically and in the CNS to the combination
of irinotecan hydrochloride and temozolomide among patients with breast cancer and
progressive brain metastases that have progressed after previous treatment for brain
metastases.

- To determine the toxicities associated with the combination of irinotecan hydrochloride
and temozolomide in breast cancer patients with progressive brain metastases.

Secondary

- To evaluate the time to first progression at any site (CNS or extra-CNS) in patients
treated with the combination of irinotecan hydrochloride and temozolomide.

- To evaluate the overall survival of patients treated with the combination of irinotecan
hydrochloride and temozolomide for brain metastases.

OUTLINE: Patients receive irinotecan IV on days 1 and 15 and oral temozolomide on days 1-7
and 15-21. Treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.

After completion of study therapy, patients are followed every 4 weeks.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed breast cancer with radiographically
confirmed metastases to the brain

- Extracranial metastases allowed

- Must have demonstrated progression of brain metastases after prior treatment for
brain metastases, including any of the following:

- External beam radiotherapy

- Brachytherapy

- Stereotactic radiosurgery

- Surgery

- Chemotherapy

- Treatments with investigational drugs, biologics, or devices

- Disease progression in the CNS must meet ≥ 1 of the following criteria:

- New lesions in the CNS on an imaging study (contrast-enhanced CT scan or MRI)

- Progressive lesions on an imaging study (contrast-enhanced CT scan or MRI)

- New or progressive lesions that do not meet measurable disease definition allowed

- Leptomeningeal disease allowed if concurrent progression or parenchymal brain
metastases

- Not a candidate for surgical resection and/or further stereotactic radiosurgery

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- ECOG performance status 0-2

- Life expectancy ≥ 1 month

- Hemoglobin ≥ 10 g/dL (transfusion allowed)

- ANC ≥ 1,500/mm³

- Granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 1.5 mg/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 3 times ULN

- Must be able to swallow and retain oral medications

- No other active malignancy except for any of the following:

- Curatively treated basal or squamous cell carcinoma of the skin

- Carcinoma in situ of the cervix

- Other malignancies considered disease-free

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No history of immediate or delayed-type hypersensitivity reaction to gadolinium
contrast agents or other contraindication to gadolinium contrast

- No other known contraindication to MRI including, but not limited to, any of the
following:

- Cardiac pacemaker

- Implanted cardiac defibrillator

- Brain aneurysm clips

- Cochlear implant

- Ocular foreign body

- Shrapnel

- No active or uncontrolled infection

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from the side effects of prior chemotherapy, surgery, or radiotherapy for
extracranial disease or brain metastases

- Concurrent trastuzumab, bisphosphonate, and/or corticosteroid therapy allowed

- At least 1 week since prior or on current stable dose of corticosteroid therapy

- Patients on an enzyme-inducing anti-epileptic agent (EIAE) or valproic acid are
eligible if they are switched to an alternate non-EIAE medication

- Concurrent coumadin allowed

- No prophylactic use of filgrastim (G-CSF) during first course of treatment

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (percentage of patients with complete or partial response) in the CNS at ≥ 16 weeks

Safety Issue:

No

Principal Investigator

Michelle Melisko, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000583265

NCT ID:

NCT00617539

Start Date:

February 2005

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Metastatic Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • male breast cancer
  • tumors metastatic to brain
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115