Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2015-10-05
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
capecitabine, 1500 mg, twice a day for 7 days on then 7 days off
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).
Group B
capecitabine, 1250 mg/m2 OR 1000 mg/m2, twice a day for 14 days on then 7 days off
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Qamar Khan
OTHER
Responsible Party
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Qamar Khan
Principal Investigator
Principal Investigators
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Qamar Khan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Cancer Center - CRC
Locations
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University of Kansas Cancer Center - CRC
Fairway, Kansas, United States
St. Catherine Hospital - Central Care Cancer Center
Garden City, Kansas, United States
Heartland Cancer Center - Central Care Cancer Center
Great Bend, Kansas, United States
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays, Kansas, United States
University of Kansas Cancer Center - West
Kansas City, Kansas, United States
Olathe Medical Center
Olathe, Kansas, United States
University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States
Via Christi Cancer Center
Pittsburg, Kansas, United States
Salina Regional Health
Salina, Kansas, United States
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States
University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
Truman Medical Center
Kansas City, Missouri, United States
University of Kansas Cancer Center - South
Kansas City, Missouri, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
Countries
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References
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Other Identifiers
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2015-IIT-X7-7
Identifier Type: -
Identifier Source: org_study_id