Standard Versus Continuous Capecitabine in Advanced Breast Cancer

NCT00418028 | Completed Phase 2 Results

• 2 other identifiers: 05/2372004-002759-15
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

Capecitabine is active in metastatic breast cancer but the conventional schedule (1250 mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in up to 50% of patients leading to those reductions. There are theoretical reasons to administer S-phase specific agents in continuous, protracted rather than intermittent schedules. The investigators study compares the standard schedule (1250 mg/m2/12 hr 2 weeks on, one week off) with a continuous administration schedule (800 mg/m2/12hr). The latter administer approximately the same cumulative dose of capecitabine as the standard schedule. The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from 50% (standard arm) to 20% (experimental arm). The investigators assume similar antitumor activity in both arms.

Conditions

Metastatic Breast Cancer

Keywords

capecitabine; schedule; breast cancer

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  Time to Progression (TTP) is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies due to progressive disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).

  After 1 year from the treatment start day.

Secondary Outcomes (6)

• Response Rate

  Through the study treatment, an average of 5 months.

• Response Duration

  Time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first, assessed up to 72 weeks.

• Time to Treatment Failure

  Time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient's decision or investigator criteria, assessed up to 72 months.

• Overall Survival

  Time to survival is the number of months from the study treatment start date to the date of death, assessed up to 100 months.

• Clinical Benefit

  Months from "CR","PR" or "SD" (the first one) until Progression date, new treatment or last contact date.

Study Arms (2)

A Cint

ACTIVE COMPARATOR

Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

Drug: Capecitabine

B Ccont

EXPERIMENTAL

Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

Drug: Capecitabine

Interventions

Capecitabine DRUG

Also known as: xeloda

A Cint; B Ccont

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with metastatic breast cancer
• Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease).
• The patient is ambulatory with a functional ECOG \< 2 status (see Appendix 2).
• Patient presents, at least one lesion measurable according to RECIST criteria (see Appendix 3)
• Patients with a life expectancy of at least 3 months.
• Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study.

You may not qualify if:

• Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile.
• Patients previously treated with capecitabine.
• Patients with organ transplants.
• Other diseases or severe affections:
• Patients with previous convulsions, central nervous system diseases or psychiatric diseases, including dementia, that the investigator might consider clinically significant and which adversely affect therapeutic compliance.
• Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression.
• Clinical significant cardiac disease (e. g. . congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not fully controlled with medication) or myocardial infarction within the last 12 months.
• Severe renal impairment (baseline creatinine clearance \< 30 ml/min)
• Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled convulsions, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded.
• Patients with an active infection.
• Patients with a history of other neoplasias during the previous five years, except for basal cell skin cancer or cervical cancer in situ, both cured.
• Patients showing the following laboratory values:
• Neutrophil count \< 555 x 109/l
• Platelet count\< 100 x 109/l
• Serum creatinine \> 1,5 x upper normality limit

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Complexo Hospitalario Universitario de A Coruña: collaborator

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Related Publications (1)

• Martin M, Martinez N, Ramos M, Calvo L, Lluch A, Zamora P, Munoz M, Carrasco E, Caballero R, Garcia-Saenz JA, Guerra E, Caronia D, Casado A, Ruiz-Borrego M, Hernando B, Chacon JI, De la Torre-Montero JC, Jimeno MA, Heras L, Alonso R, De la Haba J, Pita G, Constenla M, Gonzalez-Neira A. Standard versus continuous administration of capecitabine in metastatic breast cancer (GEICAM/2009-05): a randomized, noninferiority phase II trial with a pharmacogenetic analysis. Oncologist. 2015 Feb;20(2):111-2. doi: 10.1634/theoncologist.2014-0379. Epub 2015 Jan 19.

  PMID: 25601966 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: The Oncologist 2015;20:1-2 http://www.theoncologist.com/ Scientific Director and CEO
• Organization: GEICAM (Grupo Español de Investigación en Cancer de Mama)

geicam@geicam.org

+34916592870

Study Officials

• Miguel Martin, MD,PhD

  Hospital Clinico San Carlos

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 4, 2007
• Study Start: September 1, 2005
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2015
• Last Updated: February 22, 2019
• Results First Posted: December 18, 2017

Record last verified: 2019-02

Locations

ES (1)