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An Open-Label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Metastatic Breast Cancer Patients Following Prior Anthracycline and Taxane Therapy


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

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Trial Information

An Open-Label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Metastatic Breast Cancer Patients Following Prior Anthracycline and Taxane Therapy


Inclusion Criteria:



- Ambulant female patients with metastatic breast cancer who have been treated
previously with an anthracycline and a taxane will be enrolled.

- Patients must fulfill the following criteria to be included in the study:

- Histologically or cytologically confirmed breast cancer with at least one ---
metastatic uni-dimensionally measurable lesion according to RECIST criteria (the
following do not qualify as measurable lesions: bone, leptomeningeal disease,
ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses
that are not confirmed and followed by imaging techniques, and cystic lesions).

- Prior treatment with an anthracycline and a taxane.

- All previous treatment (including surgery and radiotherapy) must have been completed
at least 4 weeks prior to study entry and any acute toxicities must have resolved.

- Age >= 18 years.

- Karnofsky performance status of >= 70%.

- Written informed consent to participate in the study.

Exclusion Criteria:

Patients with the following characteristics will not be included in the study:

- Previously received greater than two prior chemotherapy regimens for metastatic
breast cancer.

- Previously received greater than three prior chemotherapy regimens in total
(including neo-adjuvant and adjuvant regimens) for breast cancer.

- Primary diagnosis of inflammatory breast cancer, confirmed by histology or cytology.

- Untreated brain metastases (patients who have been treated for CNS metastases must be
asymptomatic and radiologically stable for 3 months prior to entry). Patients must
not have clinical symptoms from brain metastases and must not be taking
corticosteroids for the treatment of brain metastases. Patients must not have
leptomeningeal metastases.

- Concurrent or previous malignancy of a different tumor type within five years of
starting the study except for adequately treated non-melanoma skin cancer or cervical
intraepithelial neoplasia.

- Any of the following laboratory parameters:

1. hemoglobin <10 g/dl;

2. neutrophils <1.5 x 109/L;

3. platelets <100 x 109/L;

4. serum bilirubin >25 ┬Ámol/l (1.5 mg/dl);

5. other liver parameters >2.5 x upper normal limit (ULN) (> 5 x upper normal limit
in the presence of hepatic metastases);

6. serum creatinine >1.5 x ULN;

7. serum calcium (corrected for albumin) >=11.5 mg/dl.

- Uncontrolled infections.

- Clinically significant cardiac impairment or unstable ischemic heart disease
including a myocardial infarction within six months of study start.

- Malabsorption syndrome or other condition which may affect drug absorption.

- History of hypersensitivity to sulfonamides.

- Prior severe or unexpected reaction to fluoropyrimidine therapy (which may be
explained by dihydropyrimidine dehydrogenase deficiency or hypersensitivity to
5-fluorouracil).

- Any treatment with investigational drugs within 30 days before the start of the
study.

- Pregnancy or lactation (all women of childbearing potential must have a negative
pregnancy test before inclusion in the study; post-menopausal women must be
amenorrheic for at least 12 months). Fertile patients must use adequate contraceptive
protection.

- History of alcoholism, drug addiction, or any psychiatric or psychological condition
which, in the opinion of the investigator, would impair study compliance.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Tumor measurements to be done by CT/MRI or photography in accordance with the RECIST criteria and radiography protocol provided. Six month and median overall survival, pain and analgesia score.

Principal Investigator

Jantien Wanders

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Limited

Authority:

Russia: Pharmacological Committee, Ministry of Health

Study ID:

E7070-E044-213

NCT ID:

NCT00165880

Start Date:

December 2004

Completion Date:

September 2007

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

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