Metastatic Breast CancerPhase 2NCT00192101
Gemcitabine Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines and/or Taxanes
A Phase 2 study testing gemcitabine and cisplatin in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 1 site in Saudi Arabia.
Trial summary
This is an open label, two arms, randomized, unblinded phase 2 study in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline with/without taxane based regimen in the adjuvant/neoadjuvant or 1st line metastatic setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- gemcitabine and cisplatin
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Oct 2004to Jul 2005
- 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
- Histological or cytological diagnosis of breast carcinoma with evidence of unresectable, locally recurrent, or metastatic disease. Lesions should not be amenable to surgery or radiation of curative intent.
- Presence of metastatic or local-regional recurrent disease, according to the American Joint Committee on Cancer
- Uni-dimensionally measurable lesions with clearly defined margin that are clearly measurable by following methods according to computerized tomography (CT), Chest x-ray or clinical examination, according to RECIST criteria
- Patients with unresectable, locally recurrent or metastatic breast cancer who, were pre-treated with anthracyclines with/without taxanes (paclitaxel, docetaxel)containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study. Prior chemotherapy has to be terminated 4 weeks prior. Study randomization and disease progression under this therapy has to be documented, also patients must have completely recovered from all acute chemotherapy related toxicities (with exception of alopecia).
- Prior radiotherapy must be completed at least 30 days before study entry. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment (except for alopecia). Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
Who cannot join
- Have received treatment within the last 30 days with an investigational drug for any indication before study entry.
- Concurrent administration of other tumor therapy, including cytotoxic chemotherapy, surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including Herceptin)
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy, unless adequately treated.
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment(except in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin)
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Jeddah
About this study
Official title: Randomized Phase II Study of the Combination of Gemcitabine (Gemzar) Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines an/or Taxanes
This is an open label, two arms, randomized, unblinded phase 2 study in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline with/without taxane based regimen in the adjuvant/neoadjuvant or 1st line metastatic setting. Gemcitabine will be administered via intravenous infusion over approximately 30 minutes at a dose of 1250mg/m2 on days 1 and 8 of each 21-day cycle. In arm A:Cisplatin will be given via intravenous infusion over approximately 60-120 minutes at a dose of 70 mg/m2 on Day 1 of each 21-day cycle. The investigator may attempt to give Cisplatin with at least one liter of fluids for hydration and on an outpatient basis.
Patients will remain in the study until disease progression or when a maximum of six cycles have been administered. Study therapy may continue until:
- There is evidence of progressive disease
- The patient experiences unacceptable toxicity.
- The investigator decides that the patient should be discontinued.
- The patient requests discontinuation
- The patient has received 6 cycles of the regimen (if the physician decides to continue after 6 cycles-this will be done after consultation with the sponsor)
- Discontinuation from study therapy is indicated according to the additional guidelines described in the protocol After patients discontinue from study therapy, they proceed to the post-study follow up phase of the study.
- Conditions
- Metastatic Breast Cancer
- Being tested
- gemcitabine, cisplatin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
cisplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rates of the combination of gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline with/without taxane based regimen
in the adjuvant/neoadjuvant or 1st line metastatic setting for each treatment arm separately.
Secondary outcomes (3)
To characterize the quantitative and qualitative toxicity of gemcitabine-cisplatin patient population for each treatment arm separately;Relative dose intensity of gemcitabine and cisplatin for each treatment arm separately
Rate of dose modifications (omissions, reductions, delays) for each treatment arm separately;Time to progression for each treatment arm separately;Duration of response for each treatment arm separately;1-year survival in each treatment arm separately
Overall survival in each treatment arm separately;To assess the medical resources utilization with the combination in each treatment arm separately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192101
- Sponsor's protocol ID
- 9590
- Other IDs
- B9E-SI-S371
- Status last verified
- Nov 2007
- First submitted
- 12 Sep 2005
- Last updated
- 20 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of the Combination of Gemcitabine (Gemzar) Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines an/or Taxanes
- ClinicalTrials.gov ID
- NCT00192101
- Acronym / sponsor ID
- 9590
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Jul 2005
- First posted
- 19 Sep 2005 (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 is an open label, two arms, randomized, unblinded phase 2 study in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline with/without taxane based regimen in the adjuvant/neoadjuvant or 1st line metastatic setting. Gemcitabine will be administered via intravenous infusion over approximately 30 minutes at a dose of 1250mg/m2 on days 1 and 8 of each 21-day cycle. In arm A:Cisplatin will be given via intravenous infusion over approximately 60-120 minutes at a dose of 70 mg/m2 on Day 1 of each 21-day cycle. The investigator may attempt to give Cisplatin with at least one liter of fluids for hydration and on an outpatient basis.
Patients will remain in the study until disease progression or when a maximum of six cycles have been administered. Study therapy may continue until:
- There is evidence of progressive disease
- The patient experiences unacceptable toxicity.
- The investigator decides that the patient should be discontinued.
- The patient requests discontinuation
- The patient has received 6 cycles of the regimen (if the physician decides to continue after 6 cycles-this will be done after consultation with the sponsor)
- Discontinuation from study therapy is indicated according to the additional guidelines described in the protocol After patients discontinue from study therapy, they proceed to the post-study follow up phase of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological or cytological diagnosis of breast carcinoma with evidence of unresectable, locally recurrent, or metastatic disease. Lesions should not be amenable to surgery or radiation of curative intent.
- Presence of metastatic or local-regional recurrent disease, according to the American Joint Committee on Cancer
- Uni-dimensionally measurable lesions with clearly defined margin that are clearly measurable by following methods according to computerized tomography (CT), Chest x-ray or clinical examination, according to RECIST criteria
- Patients with unresectable, locally recurrent or metastatic breast cancer who, were pre-treated with anthracyclines with/without taxanes (paclitaxel, docetaxel)containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study. Prior chemotherapy has to be terminated 4 weeks prior. Study randomization and disease progression under this therapy has to be documented, also patients must have completely recovered from all acute chemotherapy related toxicities (with exception of alopecia).
- Prior radiotherapy must be completed at least 30 days before study entry. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment (except for alopecia). Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
Key exclusion criteria (5 listed)
- Have received treatment within the last 30 days with an investigational drug for any indication before study entry.
- Concurrent administration of other tumor therapy, including cytotoxic chemotherapy, surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including Herceptin)
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy, unless adequately treated.
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment(except in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin)
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 |
|---|---|---|
| gemcitabine | Drug | – |
| cisplatin | Drug | – |
Primary outcome
Overall response rates of the combination of gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline with/without taxane based regimen
in the adjuvant/neoadjuvant or 1st line metastatic setting for each treatment arm separately.
3 secondary outcomes
To characterize the quantitative and qualitative toxicity of gemcitabine-cisplatin patient population for each treatment arm separately;Relative dose intensity of gemcitabine and cisplatin for each treatment arm separately
Rate of dose modifications (omissions, reductions, delays) for each treatment arm separately;Time to progression for each treatment arm separately;Duration of response for each treatment arm separately;1-year survival in each treatment arm separately
Overall survival in each treatment arm separately;To assess the medical resources utilization with the combination in each treatment arm separately
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 20 Nov 2007.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
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 gemcitabine and cisplatin in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 1 site in Saudi Arabia.
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 5 inclusion and 5 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 20 Nov 2007. 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 Saudi Arabia. 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?
Overall response rates of the combination of gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline with/without taxane based regimen. The study lists 2 primary outcomes in all. 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 20 Nov 2007.