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Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms, Chemotherapy

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Trial Information

Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer


Inclusion Criteria:



- Histologically proven breast adenocarcinoma

- Evaluable or measurable metastases

- HER-2 status 0 or 1 in immnohistochimy or negative in FISH/CISH

- Previously treated with anthracyclines and taxanes

- Age > = 18 y

- No more than two previous chemotherapy regimens for metastases

- No nervous central system involvement

- Hormonal therapy must have been stopped two weeks before enrollment

- Adequate biologic function

- Performance status OMS < = 2

- Signed informed consent

Exclusion Criteria:

- History of other malignancies, except basocellular cancer, in situ cervix carcinoma

- Gastro intestinal disease that might affect absorption of capecitabine

- Cardiac failure or angina pectoris uncontrolled

- Hypersensitivity for capecitabine, fluorouracil, or one of their excipient

- Known dihydropyrimidine dehydrogenase (DPD) deficiency

- Concomitant anticancer therapy (included hormonotherapy)

- Concomitant radiotherapy

- Treatment with sorivudine and analogs

- Pregnant or breast feeding patients. Contraception methods excluding hormonal
treatment is required.

- Inclusion in an experimental protocol within 30 days

Type of Study:

Interventional

Study Design:

N/A

Principal Investigator

eric levy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

HEGP , PARIS

Authority:

France: Comité National d'Ethique

Study ID:

CAP 5/7

NCT ID:

NCT00324610

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Chemotherapy
  • fluoropyrimidines
  • metastases
  • pharmacokinetics
  • phase 1-2 study
  • Breast Neoplasms
  • Neoplasms

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