Recurrent Breast CancerPhase 2NCT00077363
Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer
A Phase 2 study testing tipifarnib and capecitabine in people with Recurrent Breast Cancer and Stage IV Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well giving capecitabine together with tipifarnib works in treating women with taxane-resistant metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Breast Cancer, Stage IV Breast Cancer
- What is being tested?
- tipifarnib and capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Feb 2007
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with histologically confirmed adenocarcinoma of the breast with manifestations of metastatic progression
- Patients must have at least one objective measurable disease parameter as defined by RECIST criteria; tumor measurements and evaluation of non-measurable sites must be performed within 4 weeks prior to registration
- ECOG performance status 0-2
- In order to be eligible for inclusion, patients must meet all of the following criteria with regard to prior cytotoxic therapy: (1) prior treatment with an anthracycline (e.g., doxorubicin, epirubicin) either in the adjuvant/neoadjuvant setting and/or for metastatic disease, (2) prior treatment with a taxane (i.e. paclitaxel, docetaxel) for metastatic disease, or relapse while receiving adjuvant taxane therapy (3) progressive disease while receiving taxane therapy or up to 30 days after receiving the last taxane dose, (4) no more than three prior cytotoxic regimens for metastatic disease, (5) no prior treatment with capecitabine or 5-flourouracil for metastatic disease
- Prior hormonal therapy in either the metastatic or adjuvant/neoadjuvant setting is allowed, but patients must have been off such therapy for greater than or equal to 1 week prior to registration
- No prior radiotherapy other than to the conserved breast, to the postmastectomy chest wall or to a limited field involving less than 25% of marrow - containing bone
Show all 22Show fewer
- Previously irradiated tumors cannot be used to assess a clinical response; patients will not be eligible for this study if the previously irradiated tumors constitute the only site of measurable disease
- Patients must not have previously received tipifarnib or other farnesyl transferase inhibitors
- Patients must be disease-free of prior malignancies for > 5 years with the exception of curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix
- Patients must have serum creatinine =< 1.5 mg/dl or measured (or calculated) creatinine clearance >= 60 mL/minute
- Granulocytes > 1500/mm^3
- Platelets > 100,000/mm^3
- Total bilirubin =< 1.5 x upper limit of normal
- SGOT (AST) and SGPT (ALT) =< 3 x upper limit of normal (unless liver is involved by tumor, in which case SGOT (AST) and SGPT (ALT) can be =< 5 x upper limit of normal)
- Patients must not be pregnant or breastfeeding since there is no information regarding the use of these agents in this population; a negative serum or urine pregnancy test is required within 14 days prior to registration if pre- or perimenopausal (i.e., last menstrual period within one year of registration)
- Women of childbearing potential are strongly advised to use an accepted and effective method of contraception
- Patients with current or previously treated brain metastases are ineligible; patients who are taking enzyme inducing anticonvulsant medications are also not eligible (e.g., phenobarbital, phenytoin)
- Patients must not have had prior organ allograft or received immunosuppressive therapy
- Patients must not have any uncontrolled intercurrent illness including, but not limited to, chronic nausea/vomiting, complete or partial bowel obstruction, dysphagia/odynophagia with inability to swallow pills, ongoing or active infection, symptomatic cardiovascular disease, or other chronic medical or psychiatric conditions that would impair compliance or would substantially increase the risk of participating in this study
- Patients must not have received previous treatment with cytotoxic drugs, and/or radiotherapy < 4 weeks prior to registration; concurrent radiation therapy is not permitted
- Because of the potential for a drug interaction between warfarin and both tipifarnib and capecitabine, patients taking warfarin adjusted to an elevated INR are not eligible; patients taking prophylactic low-dose warfarin (i.e., 1 mg daily) are eligible, but a PT and INR are required within 2 weeks of registration and must be normal
- Patients with CTC v 3.0 grade 2-4 neuropathy are not eligible
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Trial of Capecitabine in Combination With the Farnesyltransferase Inhibitor, R115777 (Tipifarnib, Zarnestra) in Patients With Metastatic Breast Cancer
This phase II trial is studying how well giving capecitabine together with tipifarnib works in treating women with taxane-resistant metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving capecitabine together with tipifarnib may kill more tumor cells
Read the detailed description
PRIMARY OBJECTIVES:
- The primary objective of this study is to determine the response rate in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib.
SECONDARY OBJECTIVES:
- To evaluate toxicity in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib.
II. To evaluate progression free survival, time to treatment failure, and overall survival in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 4 additional courses beyond documentation of CR.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
- Conditions
- Recurrent Breast Cancer, Stage IV Breast Cancer
- Being tested
- tipifarnib, capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tipifarnibDrug
Also called R115777, Zarnestra
Given PO
capecitabineDrug
Also called CAPE, Ro 09-1978/000, Xeloda
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (tipifarnib, capecitabine) | Experimental | Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 4 additional courses beyond documentation of CR. Receives: Drug: tipifarnib; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (PR+CR)
Measured: Up to 5 years
Secondary outcomes (4)
Progression-free survival (PFS)
The Kaplan-Meier method will be used to estimate distributions.
Measured: From registration to progression or to death from any cause without documentation of progression, assessed up to 5 years
Time to treatment failure (TTF)
The Kaplan-Meier method will be used to estimate distributions.
Measured: From registration to disease progression, permanent discontinuation of treatment due to toxicity, or death, whichever occurs first, assessed up to 5 years
Overall survival (OS)
The Kaplan-Meier method will be used to estimate distributions.
Measured: Up to 5 years
Incidence of toxicities
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2004 (estimated)
- Study startMay 2004
- Primary completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William Gradishar, Principal investigator, Eastern Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077363
- Sponsor's protocol ID
- NCI-2012-02973
- Other IDs
- E1103, U10CA021115, CDR0000350219
- Status last verified
- Feb 2013
- First submitted
- 10 Feb 2004
- Last updated
- 27 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Capecitabine in Combination With the Farnesyltransferase Inhibitor, R115777 (Tipifarnib, Zarnestra) in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00077363
- Acronym / sponsor ID
- NCI-2012-02973
- Conditions
- Recurrent Breast Cancer, Stage IV Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2004
- Primary completion
- Feb 2007 (actual)
- First posted
- 12 Feb 2004 (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.
This phase II trial is studying how well giving capecitabine together with tipifarnib works in treating women with taxane-resistant metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving capecitabine together with tipifarnib may kill more tumor cells
Detailed description
PRIMARY OBJECTIVES:
- The primary objective of this study is to determine the response rate in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib.
SECONDARY OBJECTIVES:
- To evaluate toxicity in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib.
II. To evaluate progression free survival, time to treatment failure, and overall survival in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 4 additional courses beyond documentation of CR.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (tipifarnib, capecitabine) | Experimental | Drug: tipifarnib, Drug: capecitabinePatients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 4 additional courses beyond documentation of CR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Female patients with histologically confirmed adenocarcinoma of the breast with manifestations of metastatic progression
- Patients must have at least one objective measurable disease parameter as defined by RECIST criteria; tumor measurements and evaluation of non-measurable sites must be performed within 4 weeks prior to registration
- ECOG performance status 0-2
- In order to be eligible for inclusion, patients must meet all of the following criteria with regard to prior cytotoxic therapy: (1) prior treatment with an anthracycline (e.g., doxorubicin, epirubicin) either in the adjuvant/neoadjuvant setting and/or for metastatic disease, (2) prior treatment with a taxane (i.e. paclitaxel, docetaxel) for metastatic disease, or relapse while receiving adjuvant taxane therapy (3) progressive disease while receiving taxane therapy or up to 30 days after receiving the last taxane dose, (4) no more than three prior cytotoxic regimens for metastatic disease, (5) no prior treatment with capecitabine or 5-flourouracil for metastatic disease
- Prior hormonal therapy in either the metastatic or adjuvant/neoadjuvant setting is allowed, but patients must have been off such therapy for greater than or equal to 1 week prior to registration
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| tipifarnibAlso: R115777, ZarnestraGiven PO | Drug | Treatment (tipifarnib, capecitabine) |
| capecitabineAlso: CAPE, Ro 09-1978/000, XelodaGiven PO | Drug | Treatment (tipifarnib, capecitabine) |
Primary outcome
Objective response rate (PR+CR)
Time frame: Up to 5 years
4 secondary outcomes
Progression-free survival (PFS)
Time frame: From registration to progression or to death from any cause without documentation of progression, assessed up to 5 years
Time to treatment failure (TTF)
Time frame: From registration to disease progression, permanent discontinuation of treatment due to toxicity, or death, whichever occurs first, assessed up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Incidence of toxicities
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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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.
William Gradishar principal investigator
Eastern Cooperative Oncology Group
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 tipifarnib and capecitabine in people with Recurrent Breast Cancer and Stage IV Breast Cancer, run by National Cancer Institute (NCI) at 1 site 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 22 inclusion and 0 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: finished, as of the sponsor's last update on 27 Feb 2013. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective response rate (PR+CR) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2013.