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Clinical Study to Assess Entry of Chemotherapeutic Agents Into Brain Metastases in Women With Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Metastatic Cancer

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Trial Information

Clinical Study to Assess Entry of Chemotherapeutic Agents Into Brain Metastases in Women With Breast Cancer


OBJECTIVES:

- To determine the concentration of capecitabine, cyclophosphamide, doxorubicin
hydrochloride, gemcitabine hydrochloride, lapatinib ditosylate, paclitaxel, trastuzumab
(Herceptin®), or vinorelbine ditartrate in brain metastases in women with breast
cancer.

- To analyze drug penetrability by modeling the relationship between drug concentration
in the tumor and drug concentration in blood samples.

OUTLINE: Patients are assigned to receive 1 of the 8 agents by the patient's treating
oncologist.

Patients receive a single dose of the following study drugs immediately preceding surgery:
oral capecitabine; cyclophosphamide IV over 30 minutes; doxorubicin hydrochloride IV over 15
minutes; gemcitabine hydrochloride IV over 30 minutes; oral lapatinib ditosylate*;
paclitaxel IV over 3 hours; trastuzumab (Herceptin®) IV over 30-90 minutes; or vinorelbine
ditartrate IV over 10-30 minutes . Patients then undergo craniotomy for resection of the
brain metastases.

NOTE: *Patients receive oral lapatinib ditosylate at least 3 days prior to surgery and
immediately before surgery.

All patients receiving cyclophosphamide, doxorubicin hydrochloride, gemcitabine
hydrochloride, paclitaxel, or vinorelbine ditartrate also receive a single dose of
pegfilgrastim subcutaneously (SC) 24-48 hours after the study drug administration OR
filgrastim (G-CSF) SC once daily for 10 days, beginning 24-48 hours after the study drug
administration.

Blood samples are collected periodically for pharmacological studies. Tissue samples
obtained at surgical resection and blood samples are used to establish cell lines and
analyzed for drug concentration by HPLC, LC-MS/MS or ELISA.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed breast carcinoma with ≥ 1 suspected or
known parenchymal brain metastases for which surgical resection or biopsy is
clinically indicated

- Treating oncologist must agree that the patient would derive clinical benefit from
receiving ≥ 1 of the following study agents:

- Capecitabine, cyclophosphamide, doxorubicin hydrochloride, gemcitabine
hydrochloride, lapatinib ditosylate, paclitaxel, trastuzumab (Herceptin®), or
vinorelbine ditartrate

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- Karnofsky performance status 50-100%

- Life expectancy ≥ 3 months

- Absolute granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin (total) ≤ 1.5 times ULN

- AST ≤ 3 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for three months after
completion of study treatment

- No severe NYHA class III-IV cardiac insufficiency with uncontrolled and/or unstable
cardiac or coronary artery disease

- No history of noncompliance to medical regimens or inability or unwillingness to
return for all scheduled visits

PRIOR CONCURRENT THERAPY:

- No toxicity > grade 2 from prior chemotherapy or radiotherapy remains at the time of
study entry

- At least 60 days since prior bevacizumab

- At least 4 weeks since prior cranial radiotherapy

- At least 3 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or
mitomycin C)

- At least 2 weeks since prior non-cytotoxic drugs (e.g., small molecule-targeted
drugs)

- No concurrent experimental therapies

- Concurrent hormone therapy and/or trastuzumab (Herceptin®) allowed

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Concentration of drug

Outcome Description:

Serum/plasma concentrations: measured for all agents except trastuzumab by HPLC or LC-MS/MS. Trastuzumab concentrations measured by enzyme linked immunosorbent assay. Compared to tissue levels and the extent of change in serum/plasma during the surgical process will be noted. Tissue Concentrations: determined by HPLC/LC-MS/MS or by ELISA. The objective would be to compare tumor concentration to brain adjacent to tumor, which often has an intact BBB. The degree of BBB compromise in the specimens will be assessed through analysis of serum protein levels and hemoglobin.

Outcome Time Frame:

Post-Op Per Sample Collection

Safety Issue:

No

Principal Investigator

David M. Peereboom, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE4107

NCT ID:

NCT00795678

Start Date:

September 2008

Completion Date:

December 2013

Related Keywords:

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

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195
Memorial Sloan KetteringNew York, New York  10021