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

December 4, 2021 updated by: Qamar Khan

Randomized Open-label Trial of Dose Dense, Fixed Dose Capecitabine Compared to Standard Dose Capecitabine in Metastatic Breast Cancer and Advanced/Metastatic Gastrointestinal Cancers.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Fairway, Kansas, United States, 66205
        • University of Kansas Cancer Center - CRC
      • Garden City, Kansas, United States, 67846
        • St. Catherine Hospital - Central Care Cancer Center
      • Great Bend, Kansas, United States, 67530
        • Heartland Cancer Center - Central Care Cancer Center
      • Hays, Kansas, United States, 67601
        • Hays Medical Center Dreiling-Schmidt Cancer Institute
      • Kansas City, Kansas, United States, 66112
        • University of Kansas Cancer Center - West
      • Olathe, Kansas, United States, 66061
        • Olathe Medical Center
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center - Overland Park
      • Pittsburg, Kansas, United States, 66762
        • Via Christi Cancer Center
      • Salina, Kansas, United States, 67401
        • Salina Regional Health
      • Topeka, Kansas, United States, 66606
        • St. Francis Comprehensive Cancer Center
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center - Westwood
    • Missouri
      • Kansas City, Missouri, United States, 64154
        • University of Kansas Cancer Center - North
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center
      • Kansas City, Missouri, United States, 64131
        • University of Kansas Cancer Center - South
      • Lee's Summit, Missouri, United States, 64064
        • University of Kansas Cancer Center - Lee's Summit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 OR 1000 mg/m2 PO BID for 14 days, followed by a 7 day rest (14-7).

Other Names:
  • Xeloda®
Active Comparator: Group B
capecitabine, 1250 mg/m2 OR 1000 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 OR 1000 mg/m2 PO BID for 14 days, followed by a 7 day rest (14-7).

Other Names:
  • Xeloda®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks from the date of registration into the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Day 1 of treatment, throughout treatment, up to 2 years from Day 1 of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From Day 1 of treatment, throughout treatment, up to 2 years from Day 1 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qamar Khan

Investigators

  • Principal Investigator: Qamar Khan, MD, University of Kansas Cancer Center - CRC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

November 1, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 4, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-IIT-X7-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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