Trial record 5 of 1633 for:    gastrointestinal | Open Studies | Exclude Unknown | United States

Capecitabine in Metastatic Breast and GI Cancers (X7-7)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University of Kansas Medical Center
Sponsor:
Information provided by (Responsible Party):
Qamar Khan, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT02595320
First received: October 2, 2015
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
The purpose of this study is compare two different doses of capecitabine to see if one is better than the other in terms of efficacy and toxicity.

Condition Intervention Phase
Breast Cancer
Gastrointestinal Cancer
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Open-label Trial of Dose Dense, Fixed Dose Capecitabine Compared to Standard Dose Capecitabine in Metastatic Breast Cancer and Advanced/Metastatic Gastrointestinal Cancers.

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Twelve-week Progression Free Survival (cohort 1 only) [ Time Frame: 12 weeks from the date of registration into the study ] [ Designated as safety issue: No ]
    As the percentage of patients with progression from the date of registration to 12 weeks from that date


Secondary Outcome Measures:
  • Grade 3 or higher toxicity (cohorts 1 and 2) [ Time Frame: From Day 1 of treatment, throughout treatment, up to 2 years from Day 1 of treatment ] [ Designated as safety issue: Yes ]
    Percentage of patients having grade 3 or higher toxicity from the date of first treatment dose during the trial therapy to patient develops Grade 3 or higher toxicity.


Other Outcome Measures:
  • Objective response rate (cohorts 1 and 2) [ Time Frame: From Day 1 of treatment, throughout treatment, up to 2 years from Day 1 of treatment ] [ Designated as safety issue: No ]
    Objective response rate (complete and partial in subset of patients with measurable disease) from date of first treatment dose to disease progression


Estimated Enrollment: 200
Study Start Date: October 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
capecitabine, 1500 mg, twice a day for 7 days on then 7 days off
Drug: Capecitabine

Capecitabine will be given to participants in Arm A at 1500 mg PO BID for 7 days, followed by a 7 day rest (7-7).

Capecitabine will be given to participants in group B at 1250 mg/m2 PO BID for 14 days, followed by a 7 day rest (14-7).

Other Name: Xeloda®
Active Comparator: Group B
capecitabine, 1250 mg/m2, twice a day for 14 days on then 7 days off
Drug: Capecitabine

Capecitabine will be given to participants in Arm A at 1500 mg PO BID for 7 days, followed by a 7 day rest (7-7).

Capecitabine will be given to participants in group B at 1250 mg/m2 PO BID for 14 days, followed by a 7 day rest (14-7).

Other Name: Xeloda®

Detailed Description:

Goals of treatment of metastatic breast cancer remain largely comfort care. However, there has been improvement in median survival among women with metastatic disease over the last two decades, mainly due to availability of more effective agents. Women are now living longer with metastatic disease and are on therapy for longer periods of time. Therefore, it is increasingly important for effective therapies to be associated with less toxicity so that women can enjoy a better overall quality of life. Similar to breast cancer, goals of treatment of various GI malignancies (including metastatic colorectal cancer, metastatic gastric and esophageal cancers, and unresectable or metastatic pancreatic cancer and cholangiocarcinoma) are largely comfort care and it is important to minimize toxicity from therapy during the treatment for metastatic disease.

Capecitabine is a unique chemotherapeutic agent for two reasons. It is the only oral chemotherapy drug available to treat breast and GI malignancies, making it convenient for patients. In addition, whereas all other cytotoxic chemotherapy agents can be administered for only a few months at a time because of development of cumulative toxicities, capecitabine can be continued for many months to years if toxicities can be managed. However the optimal dosing schedule of capecitabine is not known.

This is the basis for the proposed randomized phase II trial to compare the efficacy and tolerability of capecitabine 1500 milligrams (mg) twice a day (BID), 7 days on and 7 days off schedule to capecitabine 1250 milligrams/meters squared (mg/m2) BID, 14 days on and 7 days off) in women with metastatic breast cancer and patients with advanced/metastatic GI cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with metastatic breast cancer
  • Men and women with metastatic gastrointestinal (GI) cancer
  • There is no limit to the number of prior chemotherapy or endocrine therapy regimens received. Use of a previous fluoropyrimidine-containing regimen in advanced / metastatic setting is permitted as long as the subject discontinued the regimen for reasons other than progression and received <2 cycles of therapy.
  • No restriction on the use of fluoropyrimidine-containing regimen in the neoadjuvant or adjuvant setting
  • Measurable or non-measurable disease per RECIST criteria 1.1
  • Must have completed prior chemotherapy or radiation therapy at least 2 weeks prior to registration
  • Pathologic confirmation of respective malignancies. Biopsy of metastatic disease is preferred but not mandatory.
  • Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 0-2
  • Adequate organ and marrow function as defined below:

    • Absolute neutrophil count ≥ 1,000/ microLiter (uL)
    • hemoglobin ≥ 7 g/L
    • platelets ≥ 50,000/uL
    • total bilirubin ≤ 2 X the Institutional Upper Limit of Normal (IULN)
    • o Aspartate Aminotransferase (AST) ( Serum Glutamic Oxaloacetic Transaminase [SGOT]) ≤ 5 X IULN
    • Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase [SPGT]) ≤ 5 X IULN
    • creatinine clearance > 50 milliliters per minute (ml/min)
  • Women of childbearing potential must agree to use adequate contraception.
  • Subjects may have previously treated brain or Central Nervous System (CNS) metastasis with radiation completed at least 2 weeks prior to registration. Prior radiation to places other than CNS disease must be completed at least 14 days prior to registration. Any number of prior radiation therapy regimens is allowed provided all toxicity of prior therapy is resolved to grade 1 or less.
  • Life expectancy of >3 months

Exclusion Criteria:

  • Patient has used Capecitabine in a past regimen for metastatic disease.
  • Patient is currently using, or planning to use another investigational agent.
  • Patient with known Dihydropyrimidine Dehydrogenase (DPD) deficiency
  • Patient has symptomatic brain or CNS metastases.
  • Patient has leptomeningeal disease
  • Patient is pregnant or nursing
  • Subjects must have no barriers to taking oral medications, for example uncontrolled nausea, vomiting, diarrhea at baseline, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome.
  • No recent (≤ 3months) of partial or complete bowel obstruction unless surgically corrected.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02595320

Contacts
Contact: Qamar Khan, MD 913-588-6029 qkhan@kumc.edu
Contact: Kerry Hepler, RN 913-945-7552 khepler@kumc.edu

Locations
United States, Kansas
Newman Regional Health Recruiting
Emporia, Kansas, United States, 66801
Contact: Shanna Clock, RN    620-342-1117      
University of Kansas Cancer Center - CRC Recruiting
Fairway, Kansas, United States, 66205
Contact: Kerry Hepler, RN    913-945-7552    khepler@kumc.edu   
Contact: Stella Baccaray    913-588-2437    sbaccaray@kumc.edu   
St. Catherine Hospital - Central Care Cancer Center Recruiting
Garden City, Kansas, United States, 67846
Contact: Sara Babbitt, RN    620-272-2579      
Heartland Cancer Center - Central Care Cancer Center Recruiting
Great Bend, Kansas, United States, 67530
Contact: Jamie Hutchinson, RN    620-792-5511      
Hays Medical Center Dreiling-Schmidt Cancer Institute Recruiting
Hays, Kansas, United States, 67601
Contact: Josette Klaus    785-623-5761      
University of Kansas Cancer Center - West Recruiting
Kansas City, Kansas, United States, 66112
Contact: Kristina Pringle    913-328-3206    ksharpe-pringle@kumc.edu   
Olathe Medical Center Recruiting
Olathe, Kansas, United States, 66061
Contact: Jeni Wakefield, RN    913-791-3500 ext 4096      
University of Kansas Cancer Center - Overland Park Recruiting
Overland Park, Kansas, United States, 66210
Contact: Valerie Francis    913-234-0459    vfrancis@kumc.edu   
Via Christi Cancer Center Recruiting
Pittsburg, Kansas, United States, 66762
Contact: Melinda Adair, RN    620-235-7906      
Salina Regional Health Recruiting
Salina, Kansas, United States, 67401
Contact: Melanie Leepers, RN    785-452-7038      
St. Francis Comprehensive Cancer Center Recruiting
Topeka, Kansas, United States, 66606
Contact: Michelle Kipp    785-270-5198      
University of Kansas Cancer Center - Westwood Recruiting
Westwood, Kansas, United States, 66205
Contact: Kerry Hepler, RN    913-945-7552    khepler@kumc.edu   
Contact: Stella Baccaray    913-588-2437    sbaccaray@kumc.edu   
United States, Missouri
Truman Medical Center Recruiting
Kansas City, Missouri, United States, 64108
Contact: Denise Sharp, RN    816-404-4045    Denise.Sharp@tmcmed.org   
Contact: Nikki Malomo    816-404-4093    nikki.malomo@tmc.med.org   
University of Kansas Cancer Center - South Recruiting
Kansas City, Missouri, United States, 64131
Contact: Myra Godsey, RN    816-823-6641    mgodsy@kumc.edu   
University of Kansas Cancer Center - North Recruiting
Kansas City, Missouri, United States, 64154
Contact: Jessica Slover, MD    816-584-4879    jslover@kumc.edu   
University of Kansas Cancer Center - Lee's Summit Recruiting
Lee's Summit, Missouri, United States, 64064
Contact: Justin Jones    816-350-5825    jjones10@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Principal Investigator: Qamar Khan, MD University of Kansas Cancer Center - CRC
  More Information

Publications:
Stockler M, S.T., Grimison P, et al, A randomized trial of capecitabine (C) given intermittently (IC) rather than continuously (CC) compared to classical CMF as first-line chemotherapy for advanced breast cancer (ABC). J Clin Oncol, 2007. 25(18S; June 20 suppl). Abstract 1031.
Soto C, T.L., Reyes S, et al., Capecitabine (X) and taxanes in patients (pts) with anthracycline-pretreated metastatic breast cancer (MBC): sequential vs. combined therapy results from a MOSG randomized phase III trial. J Clin Oncol., 2006. 24(18S; June 20 suppl). Abstract 570.
O'shaughnessy J, B.J., A retrospective evaluation of the impact of dose reduction in patients treated with Xeloda (capecitabine). Proc Am Soc Clin Oncol, 2000. 19: 104a. Abstract 400.

Responsible Party: Qamar Khan, Principal Investigator, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02595320     History of Changes
Other Study ID Numbers: 2015-IIT-X7-7 
Study First Received: October 2, 2015
Last Updated: March 14, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Plan to share data is undecided.

Keywords provided by University of Kansas Medical Center:
breast, gastrointestinal,capecitabine, cancer, metastatic

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Digestive System Neoplasms
Digestive System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 25, 2016