Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

NCT00324610 | Unknown Phase 1

• 2 other identifiers: CAP 5/7ARTIC / CAP 5/7
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity. Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen. Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen

Conditions

Breast Neoplasms; Chemotherapy

Keywords

fluoropyrimidines; metastases; pharmacokinetics; phase 1-2 study

Interventions

capecitabine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie: lead

Study Sites (1)

Ho¨Pital Europeen Georges Pompidou

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• eric levy, MD

  HEGP , PARIS

  PRINCIPAL INVESTIGATOR

• joseph Gligorov, MD

  HOPITAL TENON, PARIS

  STUDY CHAIR

• Michèle TUBIANA HULIN, MD

  CENTRE RENE HUGUENIN, SAINT CLOUD, FRANCE

  STUDY CHAIR

• VERONIQUE DIERAS, MD

  INSTITUT CURIE, PARIS france

  STUDY CHAIR

• Rémi LARGILLIER, MD

  centre antoine lacassagne, NICE, France

  STUDY CHAIR

Central Study Contacts

eric levy, md

CONTACT

33-1-56092985; eric.levy@egp.aphp.fr

kahina rideller, CRA

CONTACT

33-1-56093433; kahina.rideller@egp.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 9, 2006
• First Posted: May 11, 2006
• Study Start: March 1, 2006
• Last Updated: May 18, 2006

Record last verified: 2006-05

Locations

FR (1)