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Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy


OBJECTIVES:

- Determine the therapeutic activity of oxaliplatin in patients with advanced or
metastatic breast cancer following failure of anthracycline/taxane based chemotherapy.

- Determine objective response, duration of response, and time to progression in these
patients when treated with this regimen.

- Determine the acute side effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment continues every 3 weeks in
the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression and then every 3 months for
survival.

PROJECTED ACCRUAL: A total of 27-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed advanced or metastatic breast cancer

- Bidimensionally measurable disease

- At least one lesion at least 2 cm in one dimension by CT scan or MRI

- Must have failed prior anthracycline/taxane based chemotherapy as defined by one of
the following:

- Stage IV disease treated with anthracycline/taxane combination as first line
therapy for advanced or metastatic disease

- Stage IV disease treated with first line anthracycline therapy and second line
taxane therapy for advanced or metastatic disease

- Any adjuvant treatment other than anthracycline based therapy followed by
anthracycline/taxane combination as first line therapy for advanced or
metastatic disease

- Any adjuvant therapy other than anthracycline based therapy followed by first
line anthracycline based therapy and second line taxane based therapy for
advanced or metastatic disease

- Adjuvant anthracycline based therapy followed by relapse after 6 months treated
with anthracycline/taxane combination as first line therapy or first line
anthracycline based therapy and second line taxane based therapy for advanced or
metastatic disease

- Adjuvant anthracycline based therapy followed by relapse within 6 months treated
with first line taxane based therapy for advanced or metastatic disease

- Disease progression within 6 months of last taxane based chemotherapy

- No brain metastases

- Hormonal receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- WHO 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Absolute neutrophil count greater than 2,000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than
5 times ULN in case of liver metastases)

Renal:

- Creatinine less than 1.25 times ULN

Cardiovascular:

- LVEF at least 50% if prior total dose of doxorubicin 550 mg/m2 or greater, epirubicin
900 mg/m2 or greater, or pirarubicin 700 mg/m2 or greater

- No prior or active congestive heart failure, myocardial infarction, or angina

- No uncontrolled hypertension or arrhythmia

Other:

- No unstable systemic disease

- No active infection

- No grade 2 or greater peripheral neuropathy

- No psychological, familial, sociological, or geographical condition that would
preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior high dose chemotherapy with hematopoietic rescue

- No concurrent immunotherapy

- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) for prevention of
neutropenia

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

- At least 1 prior taxane based chemotherapy for advanced or metastatic disease

- No prior high dose chemotherapy with hematopoietic rescue

- No prior platinum based chemotherapy

- No prior taxane chemotherapy other than docetaxel or paclitaxel

- No prior adjuvant or neoadjuvant therapy with taxane/anthracycline based combination
chemotherapy

Endocrine therapy:

- No concurrent steroids except in case of allergy prevention, emesis prophylaxis, or
long term treatment for more than 3 months prior to study

- No concurrent hormonal anticancer therapy

Radiotherapy:

- No prior radiotherapy to study site unless evidence of disease progression

- Concurrent local radiotherapy allowed for pain relief

Surgery:

- At least 4 weeks since prior major surgery

Other:

- At least 4 weeks since prior anticancer and/or investigational drug

- No concurrent bisphosphonates unless started at least 2 months prior to study

- No other concurrent anticancer therapy

- No other concurrent experimental drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Pierre Fumoleau, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Authority:

United States: Federal Government

Study ID:

EORTC-16001-10005

NCT ID:

NCT00006121

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage III breast cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

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