Breast CancerPhase 2NCT00589901
An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC)
A Phase 2 study testing capecitabine and cyclophosphamide in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the time to progression. Secondary objectives are safety, OS and pharmacogenetic analysis. Sixty patients will be enrolled into this study. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- capecitabine and cyclophosphamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2006to Dec 2008
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed breast cancer
- Anthracycline and taxane pretreated metastatic breast cancer
- Have not been previously treated with capecitabine
- ECOG performance status of ≤ 1
- Are female and ≥ 18 and ≤ 70 years of age
- Have at least one target lesion according to the RECIST criteria
Who cannot join
- Pregnant or lactating women
- ECOG ≥ 2
- Have been treated with capecitabine
- Evidence of CNS metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
- Abnormal laboratory values: hemoglobin < 8.0 g/dl, neutrophils < 1.5×10^9/L, platelets < 100×10^9/L, serum creatinine > upper limit of normal (ULN), serum bilirubin > ULN, ALT and AST > 5×ULN, AKP > 5×ULN
- Serious uncontrolled intercurrent infection
- Life expectancy of less than 3 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, +86200032
Xichun Hu, MD, PhD
About this study
Official title: Phase II Study of an All-Oral Combination of Capecitabine (X) and Cyclophosphamide (C) in Patients With Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer
The primary objective of this study is to evaluate the time to progression. Secondary objectives are safety, OS and pharmacogenetic analysis. Sixty patients will be enrolled into this study.
Read the detailed description
Xeloda (capecitabine) is converted to 5-fluorouracil by thymidine phosphorylase, and cyclophosphamide is capable of upregulating the expression of thymidine phosphorylase suggesting a synergistic effect.
- Conditions
- Breast Cancer
- Being tested
- capecitabine and cyclophosphamide
- Keywords
- metastatic breast cancer, capecitabine, synergistic effect, chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine and cyclophosphamideDrug
Also called Xeloda
capecitabine 1000 mg/m2 oral Bid d1-14
cyclophosphamide 65 mg/m2 oral Qd d1-14
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | phase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer Receives: Drug: capecitabine and cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
TTP (first treatment of this regimen to disease progression)
Measured: every two cycles
Secondary outcomes (2)
side effects
Measured: all cycles
pharmacogenetic analysis
Measured: collect blood samples before this therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startAug 2006
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Zhonghua Wang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589901
- Sponsor's protocol ID
- 200507CX
- Status last verified
- Apr 2008
- First submitted
- 26 Dec 2007
- Last updated
- 18 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Fumoleau 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 14962720Endo M, Shinbori N, Fukase Y, Sawada N, Ishikawa T, Ishitsuka H, Tanaka Y. Induction of thymidine phosphorylase expression and enhancement of efficacy of capecitabine or 5'-deoxy-5-fluorouridine by cyclophosphamide in mammary tumor models. Int J Cancer. 1999 Sep 24;83(1):127-34. doi: 10.1002/(sici)1097-0215(19990924)83:13.0.co;2-6.
PubMed 10449619Wang Z, Lu J, Leaw S, Hong X, Wang J, Shao Z, Hu X. An all-oral combination of metronomic cyclophosphamide plus capecitabine in patients with anthracycline- and taxane-pretreated metastatic breast cancer: a phase II study. Cancer Chemother Pharmacol. 2012 Feb;69(2):515-22. doi: 10.1007/s00280-011-1728-3. Epub 2011 Aug 27.
PubMed 21874317
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of an All-Oral Combination of Capecitabine (X) and Cyclophosphamide (C) in Patients With Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00589901
- Acronym / sponsor ID
- 200507CX
- Conditions
- Breast Cancer
- Keywords
- metastatic breast cancer, capecitabine, synergistic effect, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 10 Jan 2008 (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 primary objective of this study is to evaluate the time to progression. Secondary objectives are safety, OS and pharmacogenetic analysis. Sixty patients will be enrolled into this study.
Detailed description
Xeloda (capecitabine) is converted to 5-fluorouracil by thymidine phosphorylase, and cyclophosphamide is capable of upregulating the expression of thymidine phosphorylase suggesting a synergistic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: capecitabine and cyclophosphamidephase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed breast cancer
- Anthracycline and taxane pretreated metastatic breast cancer
- Have not been previously treated with capecitabine
- ECOG performance status of ≤ 1
- Are female and ≥ 18 and ≤ 70 years of age
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- ECOG ≥ 2
- Have been treated with capecitabine
- Evidence of CNS metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
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 |
|---|---|---|
| capecitabine and cyclophosphamideAlso: Xelodacapecitabine 1000 mg/m2 oral Bid d1-14 cyclophosphamide 65 mg/m2 oral Qd d1-14 | Drug | A |
Primary outcome
TTP (first treatment of this regimen to disease progression)
Time frame: every two cycles
2 secondary outcomes
side effects
Time frame: all cycles
pharmacogenetic analysis
Time frame: collect blood samples before this therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2008.
- 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 10449619Endo M, Shinbori N, Fukase Y, Sawada N, Ishikawa T, Ishitsuka H, Tanaka Y. Induction of thymidine phosphorylase expression and enhancement of efficacy of capecitabine or 5'-deoxy-5-fluorouridine by cyclophosphamide in mammary tumor models. Int J Cancer. 1999 Sep 24;83(1):127-34. doi: 10.1002/(sici)1097-0215(19990924)83:13.0.co;2-6.
- Derived from this study: PubMed 21874317Wang Z, Lu J, Leaw S, Hong X, Wang J, Shao Z, Hu X. An all-oral combination of metronomic cyclophosphamide plus capecitabine in patients with anthracycline- and taxane-pretreated metastatic breast cancer: a phase II study. Cancer Chemother Pharmacol. 2012 Feb;69(2):515-22. doi: 10.1007/s00280-011-1728-3. Epub 2011 Aug 27.
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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.
Zhonghua Wang, MD principal investigator
Fudan University
1 site 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 and cyclophosphamide in people with Breast Cancer, run by Fudan University at 1 site in China.
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 6 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 18 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Zhonghua Wang, MD (8613918322628, zhonghuawang95@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TTP (first treatment of this regimen to disease progression) (time frame: every two cycles). 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 NCT00589901, which also lists 3 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 18 Apr 2008.