Breast CancerPhase 2X7-7NCT02595320
Capecitabine in Metastatic Breast and GI Cancers
A Phase 2 study testing Capecitabine in people with Breast Cancer and Gastrointestinal Cancer, run by Qamar Khan at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Gastrointestinal Cancer
- What is being tested?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 15 sitesUnited States
- Study dates
- 5 Oct 2015to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Kansas Cancer Center - CRC
Fairway, Kansas, 66205
St. Catherine Hospital - Central Care Cancer Center
Garden City, Kansas, 67846
Heartland Cancer Center - Central Care Cancer Center
Great Bend, Kansas, 67530
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays, Kansas, 67601
University of Kansas Cancer Center - West
Kansas City, Kansas, 66112
Truman Medical Center
Kansas City, Missouri, 64108
University of Kansas Cancer Center - South
Kansas City, Missouri, 64131
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Olathe Medical Center
Olathe, Kansas, 66061
University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, 66210
Via Christi Cancer Center
Pittsburg, Kansas, 66762
Salina Regional Health
Salina, Kansas, 67401
St. Francis Comprehensive Cancer Center
Topeka, Kansas, 66606
University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
About this study
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.
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.
Read the 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.
- Conditions
- Breast Cancer, Gastrointestinal Cancer
- Being tested
- Capecitabine
- Keywords
- breast, gastrointestinal,capecitabine, cancer, metastatic
- Medical subject headings
- Breast Neoplasms, Gastrointestinal Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda®
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | capecitabine, 1500 mg, twice a day for 7 days on then 7 days off Receives: Drug: Capecitabine |
| Group B | Active comparator | capecitabine, 1250 mg/m2 OR 1000 mg/m2, twice a day for 14 days on then 7 days off Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks from the date of registration into the study
Secondary outcomes (1)
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.
Measured: From Day 1 of treatment, throughout treatment, up to 2 years from Day 1 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start5 Oct 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qamar Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qamar Khan, University of Kansas Medical Center
- Investigators
- Qamar Khan, MD, Principal investigator, University of Kansas Cancer Center - CRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595320
- Sponsor's protocol ID
- 2015-IIT-X7-7
- Acronym
- X7-7
- Status last verified
- Dec 2021
- First submitted
- 2 Oct 2015
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chia SK, Speers CH, D'yachkova Y, Kang A, Malfair-Taylor S, Barnett J, Coldman A, Gelmon KA, O'reilly SE, Olivotto IA. The impact of new chemotherapeutic and hormone agents on survival in a population-based cohort of women with metastatic breast cancer. Cancer. 2007 Sep 1;110(5):973-9. doi: 10.1002/cncr.22867.
PubMed 17647245Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol. 1997 Jan;15(1):110-5. doi: 10.1200/JCO.1997.15.1.110.
PubMed 8996131Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Muller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. doi: 10.1016/S1470-2045(12)70116-X. Epub 2012 Apr 13.
PubMed 22503032Kopf B, De Giorgi U, Zago S, Carminati O, Rosti G, Marangolo M. Innovative therapy for patients with brain metastases: oral treatments. J Chemother. 2004 Nov;16 Suppl 5:94-7. doi: 10.1080/1120009x.2004.11782396.
PubMed 15675490Fumoleau P, Largillier R, Clippe C, Dieras V, Orfeuvre H, Lesimple T, Culine S, Audhuy B, Serin D, Cure H, Vuillemin E, Morere JF, Montestruc F, Mouri Z, Namer M. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer. 2004 Mar;40(4):536-42. doi: 10.1016/j.ejca.2003.11.007.
PubMed 14962720Oshaughnessy JA, Blum J, Moiseyenko V, Jones SE, Miles D, Bell D, Rosso R, Mauriac L, Osterwalder B, Burger HU, Laws S. Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol. 2001 Sep;12(9):1247-54. doi: 10.1023/a:1012281104865.
PubMed 11697835Blum JL, Dieras V, Lo Russo PM, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, Phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer. 2001 Oct 1;92(7):1759-68. doi: 10.1002/1097-0142(20011001)92:73.0.co;2-a.
PubMed 11745247Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, Osterwalder B, Burger HU, Brown CS, Griffin T. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1999 Feb;17(2):485-93. doi: 10.1200/JCO.1999.17.2.485.
PubMed 10080589Mackean M, Planting A, Twelves C, Schellens J, Allman D, Osterwalder B, Reigner B, Griffin T, Kaye S, Verweij J. Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J Clin Oncol. 1998 Sep;16(9):2977-85. doi: 10.1200/JCO.1998.16.9.2977.
PubMed 9738566Leonard R, O'Shaughnessy J, Vukelja S, Gorbounova V, Chan-Navarro CA, Maraninchi D, Barak-Wigler N, McKendrick JJ, Harker WG, Bexon AS, Twelves C. Detailed analysis of a randomized phase III trial: can the tolerability of capecitabine plus docetaxel be improved without compromising its survival advantage? Ann Oncol. 2006 Sep;17(9):1379-85. doi: 10.1093/annonc/mdl134.
PubMed 16966367Norton L. Conceptual and practical implications of breast tissue geometry: toward a more effective, less toxic therapy. Oncologist. 2005 Jun-Jul;10(6):370-81. doi: 10.1634/theoncologist.10-6-370.
PubMed 15967831Traina TA, Dugan U, Higgins B, Kolinsky K, Theodoulou M, Hudis CA, Norton L. Optimizing chemotherapy dose and schedule by Norton-Simon mathematical modeling. Breast Dis. 2010;31(1):7-18. doi: 10.3233/BD-2009-0290.
PubMed 20519801Traina TA, Theodoulou M, Feigin K, Patil S, Tan KL, Edwards C, Dugan U, Norton L, Hudis C. Phase I study of a novel capecitabine schedule based on the Norton-Simon mathematical model in patients with metastatic breast cancer. J Clin Oncol. 2008 Apr 10;26(11):1797-802. doi: 10.1200/JCO.2007.13.8388.
PubMed 18398145Gajria D, Feigin K, Tan LK, Patil S, Geneus S, Theodoulou M, Norton L, Hudis CA, Traina TA. Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer. Cancer. 2011 Sep 15;117(18):4125-31. doi: 10.1002/cncr.25992. Epub 2011 Mar 8.
PubMed 21387266Ou SH, Holcombe RF. Capecitabine in advanced gastric or oesophagogastric cancer: a viewpoint by Sai-Hong Ignatius Ou and Randall F. Holcombe. Drugs. 2007;67(4):611-2. doi: 10.2165/00003495-200767040-00011. No abstract available.
PubMed 17352521
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02595320
- Acronym / sponsor ID
- X7-7 / 2015-IIT-X7-7
- Conditions
- Breast Cancer, Gastrointestinal Cancer
- Keywords
- breast, gastrointestinal,capecitabine, cancer, metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Qamar KhanUniversity, hospital or other
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Capecitabinecapecitabine, 1500 mg, twice a day for 7 days on then 7 days off |
| Group B | Active comparator | Drug: Capecitabinecapecitabine, 1250 mg/m2 OR 1000 mg/m2, twice a day for 14 days on then 7 days off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: Xeloda®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). | Drug | Group A, Group B |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Background: PubMed 17647245Chia SK, Speers CH, D'yachkova Y, Kang A, Malfair-Taylor S, Barnett J, Coldman A, Gelmon KA, O'reilly SE, Olivotto IA. The impact of new chemotherapeutic and hormone agents on survival in a population-based cohort of women with metastatic breast cancer. Cancer. 2007 Sep 1;110(5):973-9. doi: 10.1002/cncr.22867.
- Background: PubMed 8996131Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol. 1997 Jan;15(1):110-5. doi: 10.1200/JCO.1997.15.1.110.
- Background: PubMed 22503032Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Muller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. doi: 10.1016/S1470-2045(12)70116-X. Epub 2012 Apr 13.
- Background: PubMed 15675490Kopf B, De Giorgi U, Zago S, Carminati O, Rosti G, Marangolo M. Innovative therapy for patients with brain metastases: oral treatments. J Chemother. 2004 Nov;16 Suppl 5:94-7. doi: 10.1080/1120009x.2004.11782396.
- Background: PubMed 14962720Fumoleau P, Largillier R, Clippe C, Dieras V, Orfeuvre H, Lesimple T, Culine S, Audhuy B, Serin D, Cure H, Vuillemin E, Morere JF, Montestruc F, Mouri Z, Namer M. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer. 2004 Mar;40(4):536-42. doi: 10.1016/j.ejca.2003.11.007.
- Background: PubMed 11697835Oshaughnessy JA, Blum J, Moiseyenko V, Jones SE, Miles D, Bell D, Rosso R, Mauriac L, Osterwalder B, Burger HU, Laws S. Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol. 2001 Sep;12(9):1247-54. doi: 10.1023/a:1012281104865.
- Background: PubMed 11745247Blum JL, Dieras V, Lo Russo PM, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, Phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer. 2001 Oct 1;92(7):1759-68. doi: 10.1002/1097-0142(20011001)92:73.0.co;2-a.
- Background: PubMed 10080589Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, Osterwalder B, Burger HU, Brown CS, Griffin T. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1999 Feb;17(2):485-93. doi: 10.1200/JCO.1999.17.2.485.
- Background: PubMed 9738566Mackean M, Planting A, Twelves C, Schellens J, Allman D, Osterwalder B, Reigner B, Griffin T, Kaye S, Verweij J. Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J Clin Oncol. 1998 Sep;16(9):2977-85. doi: 10.1200/JCO.1998.16.9.2977.
- Background: PubMed 16966367Leonard R, O'Shaughnessy J, Vukelja S, Gorbounova V, Chan-Navarro CA, Maraninchi D, Barak-Wigler N, McKendrick JJ, Harker WG, Bexon AS, Twelves C. Detailed analysis of a randomized phase III trial: can the tolerability of capecitabine plus docetaxel be improved without compromising its survival advantage? Ann Oncol. 2006 Sep;17(9):1379-85. doi: 10.1093/annonc/mdl134.
- Background: PubMed 15967831Norton L. Conceptual and practical implications of breast tissue geometry: toward a more effective, less toxic therapy. Oncologist. 2005 Jun-Jul;10(6):370-81. doi: 10.1634/theoncologist.10-6-370.
- Background: PubMed 20519801Traina TA, Dugan U, Higgins B, Kolinsky K, Theodoulou M, Hudis CA, Norton L. Optimizing chemotherapy dose and schedule by Norton-Simon mathematical modeling. Breast Dis. 2010;31(1):7-18. doi: 10.3233/BD-2009-0290.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qamar Khan, MD principal investigator
University of Kansas Cancer Center - CRC
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with Breast Cancer and Gastrointestinal Cancer, run by Qamar Khan at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twelve-week Progression Free Survival (cohort 1 only) (time frame: 12 weeks from the date of registration into the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02595320, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.