Xeloda (Capecitabine) and External Beam Radiation

NCT00916578 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2009-0087NCI-2012-01266
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find out if Xeloda® (capecitabine) and radiation therapy can help to control breast cancer that did not respond well to chemotherapy. The safety of this study treatment will also be studied.

Conditions

Breast Cancer

Keywords

Advanced Inflammatory Breast Cancer; Non-Inflammatory Breast Cancer; Capecitabine; Xeloda; Concomitant Radiation; Radiation Therapy; Radiotherapy; Women

Outcome Measures

Primary Outcomes (1)

• Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins.

  The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.

  Participants were monitored from 2009 to 2012.

Study Arms (1)

Radiation Therapy + Capecitabine

EXPERIMENTAL

Capecitabine 825 mg/m2 twice a day. One of the two daily doses of capecitabine should be taken approximately 2 hours before receiving radiotherapy. The first day of Capecitabine is same day that radiotherapy is started, and last day that Capecitabine is given is last day of radiotherapy. Capecitabine administered only on days patient receives radiation therapy. Radiation therapy dose 50-57 Gy to initial clinical target volume (CTV, gross disease + tissue at risk for micrometastatic disease including margin around gross disease and draining regional lymphatics).

Radiation: Radiation Therapy; Drug: Capecitabine

Interventions

Radiation Therapy RADIATION

50-57 Gy per faction once or twice a day, 5 days a week, for about 5 -7 weeks, about 15-30 minutes each time.

Also known as: RT, Radiotherapy

Radiation Therapy + Capecitabine

Capecitabine DRUG

During 5-7 weeks of radiation therapy, 825 mg/m2 (pills) by mouth, 2 times a day, about 12 hours apart, 30 minutes after eating food and about 2 hours before radiation therapy.

Also known as: Xeloda

Radiation Therapy + Capecitabine

Eligibility Criteria

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

You may qualify if:

• Histological confirmation of invasive breast cancer
• No contraindications to receiving a course of radiation treatment (pregnancy, prior radiation to the volume with disease, or systemic disease in which radiation therapy is an absolute contraindication)
• Patients who have chemo-refractory gross disease in the breast causing symptoms (pain, drainage, duress) OR gross disease in the breast (greater than or equal to T3) and/or lymph node(s) progressive, persistent, or minimally responsive to chemotherapy deemed inoperable or questionable inoperable OR Recurrent gross disease in a previously unirradiated breast or on the chest wall or in the regional lymphatics (core biopsy will not be offered to patients without gross disease in the breast).
• Are able to swallow and retain oral medication (intact pill)
• Age over 18
• Female gender

You may not qualify if:

• Have an active or uncontrolled infection
• Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
• Have used an investigational drug within 21 days preceding the first dose of study medication
• Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin)
• Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or physical exam
• Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; 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: Woodward,Wendy,M.D., PH.D.
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7734

Study Officials

• Wendy Woodward, MD, PHD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 9, 2009
• Study Start: June 5, 2009
• Primary Completion: June 6, 2017
• Study Completion: June 6, 2017
• Last Updated: July 26, 2018
• Results First Posted: June 28, 2018

Record last verified: 2018-06

Locations

US (1)