A Phase 2 interventional study of Capecitabine in Breast Cancer and Gastrointestinal Cancer, sponsored by Qamar Khan. Status unknown at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-20.
Sponsored by Qamar Khan · Phase 2, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 200 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Qamar Khan is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate organ and marrow function as defined below:
Exclusion Criteria:
capecitabine, 1500 mg, twice a day for 7 days on then 7 days off
Drug: Capecitabine
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).
Also known as: Xeloda®
Twelve-week Progression Free Survival (cohort 1 only)
As the percentage of patients with progression from the date of registration to 12 weeks from that date
Time frame: 12 weeks from the date of registration into the study
Grade 3 or higher toxicity (cohorts 1 and 2)
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.
Time frame: From Day 1 of treatment, throughout treatment, up to 2 years from Day 1 of treatment
Objective response rate (cohorts 1 and 2)
Objective response rate (complete and partial in subset of patients with measurable disease) from date of first treatment dose to disease progression
Time frame: From Day 1 of treatment, throughout treatment, up to 2 years from Day 1 of treatment
Plan to share: No
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Qamar Khan