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

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ClinicalTrials.gov Identifier: NCT02595320
Recruitment Status : Recruiting
First Posted : November 3, 2015
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Qamar Khan, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE October 2, 2015
First Posted Date  ICMJE November 3, 2015
Last Update Posted Date January 16, 2018
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2015)
Twelve-week Progression Free Survival (cohort 1 only) [ Time Frame: 12 weeks from the date of registration into the study ]
As the percentage of patients with progression from the date of registration to 12 weeks from that date
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02595320 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
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 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2015)
Grade 3 or higher toxicity (cohorts 1 and 2) [ Time Frame: During trial therapy ]
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.
Current Other Pre-specified Outcome Measures
 (submitted: March 14, 2016)
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 ]
Objective response rate (complete and partial in subset of patients with measurable disease) from date of first treatment dose to disease progression
Original Other Pre-specified Outcome Measures
 (submitted: November 1, 2015)
Objective response rate (cohorts 1 and 2) [ Time Frame: During trial terapy ]
Objective response rate (complete and partial in subset of patients with measurable disease) from date of first treatment dose to disease progression
 
Descriptive Information
Brief Title  ICMJE Capecitabine in Metastatic Breast and GI Cancers
Official Title  ICMJE Randomized Open-label Trial of Dose Dense, Fixed Dose Capecitabine Compared to Standard Dose Capecitabine in Metastatic Breast Cancer and Advanced/Metastatic Gastrointestinal Cancers.
Brief Summary The purpose of this study is compare different doses of capecitabine to see if one is better than the other in terms of efficacy and toxicity.
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) or 1000 mg/m2 BID, 14 days on and 7 days off, in women with metastatic breast cancer or patients with advanced/metastatic GI cancer.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Gastrointestinal Cancer
Intervention  ICMJE 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 OR 1000 mg/m2 PO BID for 14 days, followed by a 7 day rest (14-7).

Other Name: Xeloda®
Study Arms  ICMJE
  • Experimental: Group A
    capecitabine, 1500 mg, twice a day for 7 days on then 7 days off
    Intervention: Drug: Capecitabine
  • Active Comparator: Group B
    capecitabine, 1250 mg/m2 OR 1000 mg/m2, twice a day for 14 days on then 7 days off
    Intervention: Drug: Capecitabine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2016)
200
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2015)
183
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women with metastatic breast cancer OR 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.
  • No restriction on the use of fluoropyrimidine-containing regimen in the neoadjuvant or adjuvant setting
  • For metastatic colorectal cancers, patients starting maintenance capecitabine after a course of oxaliplatin or irinotecan based chemotherapy are eligible.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kerry Hepler ctnursenav@kumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02595320
Other Study ID Numbers  ICMJE 2015-IIT-X7-7
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Plan to share data is undecided.
Responsible Party Qamar Khan, University of Kansas Medical Center
Study Sponsor  ICMJE Qamar Khan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qamar Khan, MD University of Kansas Cancer Center - CRC
PRS Account University of Kansas Medical Center
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP