Irinotecan and Temozolomide in Treating Patients With Breast Cancer Who Have Received Previous Treatment for Brain Metastases - Full Text View

Sponsor:	University of California, San Francisco
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00617539

Purpose

RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving irinotecan together with temozolomide and to see how well it works in treating patients with breast cancer who have received previous treatment for brain metastases.

Condition	Intervention	Phase
Breast Cancer Metastatic Cancer	Drug: irinotecan hydrochloride Drug: temozolomide	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Temozolomide Irinotecan U 101440E Irinotecan hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Objective response rate (percentage of patients with complete or partial response) in the CNS at ≥ 16 weeks [ Designated as safety issue: No ]

Estimated Enrollment:	37
Study Start Date:	February 2005
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Detailed Description:

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.

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617539

Locations

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center	Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222

Sponsors and Collaborators

University of California, San Francisco

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Michelle Melisko, MD

University of California, San Francisco

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Michelle Melisko, UCSF Helen Diller Family Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00617539 History of Changes
Other Study ID Numbers:	CDR0000583265, UCSF-05751
Study First Received:	February 15, 2008
Last Updated:	August 25, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent breast cancer
stage IV breast cancer
male breast cancer
tumors metastatic to brain

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Temozolomide
Dacarbazine
Irinotecan
Camptothecin

Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012