Breast CancerPhase 2NCT00470249
Carboplatin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Breast Cancer
A Phase 2 study testing Carboplatin and Gemcitabine Hydrochloride in people with Breast Cancer, run by University of Southampton at 3 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Carboplatin and Gemcitabine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 15 Jul 2006to 3 Nov 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DISEASE CHARACTERISTICS: histologically confirmed breast cancer, locally advanced or metastatic disease, recurrent or refractory disease, histological or cytological confirmation required for recurrence in a solitary site
- Must have received prior anthracycline and taxane as neoadjuvant, adjuvant, or metastatic therapy
- At least 1 measurable site of disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Palpable disease allowed, Lesions that have been irradiated in the advanced setting cannot be included as sites of measurable disease
- No nonmeasurable disease only, including the following:
- Bone lesions
Show all 45Show fewer
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Inflammatory breast disease
- Lymphangitic pulmonary disease
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- No HER2-positive disease, defined as 3+ by IHC OR positive by FISH or chromogenic in situ hybridization
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Male or female, Menopausal status not specified, ECOG performance status 0-1, Estimated life expectancy ≥ 12 weeks, Not pregnant or nursing, fertile patients must use effective contraception during and for 3 months after completion of study therapy
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- ALT or AST < 2.5 times upper limit of normal (ULN)
- Bilirubin normal
- Alkaline phosphatase ≤ 2.5 times ULN
- Creatinine ≤ 1.25 times ULN OR creatinine clearance > 40 mL/min
- Calcium ≤ 1.2 times ULN
- No concurrent serious medical or psychiatric illness, including any serious active infection incompatible with the study
- No other primary malignancy except carcinoma in situ of the cervix, adequately treated nonmelanomatous skin cancer, or any other malignancy previously treated ≥ 5 years ago with no evidence of recurrence
- No peripheral neuropathy ≥ grade 2
- PRIOR CONCURRENT THERAPY (See Disease Characteristics):
- Recovered from prior chemotherapy
- Prior hormonal therapy or immunotherapy allowed
- Antitumoral hormonal therapy must be discontinued prior to study entry
- More than 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to the whole pelvis or to ≥ 25% of the bone marrow
- No prior gemcitabine hydrochloride, cisplatin, or carboplatin
- No other cytotoxic chemotherapy for 21 days before and for 14 days after completion of study therapy
- More than 30 days since prior treatment with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry
- Bisphosphonate therapy may not be initiated or discontinued within 4 weeks of study entry
- No more than 1 prior course of chemotherapy for metastatic disease
- Prior chemotherapy in the adjuvant setting allowed
- Concurrent palliative radiotherapy to existing painful lesions (soft tissue or bone) allowed
- New bone pain requiring radiotherapy > 4 weeks after first study treatment considered disease progression
- New pain in a soft tissue lesion without other objective changes may be irradiated provided ≥ 1 other site of nonirradiated measurable disease exists
- No other concurrent anticancer treatment
- No concurrent tamoxifen citrate, aromatase inhibitors, or progestagens
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth, England, PO3 6AD
Southampton General Hospital
Southampton, England, SO16 6YD
About this study
Official title: A Phase II Study of Carboplatin in Combination With Gemcitabine as a Dose Dense Schedule in Patients With Locally Advanced or Metastatic Breast Cancer That Are Resistant to Anthracyclines & Taxanes
RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin together with gemcitabine works in treating patients with locally advanced or metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the overall response rate in patients with anthracycline- and taxane-resistant locally advanced or metastatic breast cancer treated with dose-dense carboplatin and gemcitabine hydrochloride.
Secondary
- Determine the overall toxicity of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
- Determine the time to disease progression in patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine the time to treatment failure in patients treated with this regimen.
OUTLINE: This is a nonrandomized, open-label study.
Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 150 minutes on day 2. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- Carboplatin, Gemcitabine Hydrochloride
- Keywords
- stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, male breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
At a dose equivalent to an area under the concentration-time curve of 4.5 mg/ml.min on day 1 of every 2-week cycle
1500 mg/m2 on day 2 of every 2-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Patients with (HER-2)-negative and anthracycline- and taxane-resistant | Experimental | Patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant Receives: Drug: Carboplatin; Drug: Gemcitabine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (complete or partial response)
Assess the Overall response rate (complete or partial response)
Measured: 8 months
Secondary outcomes (5)
Overall toxicity as assessed by NCI CTCAE v3.0
Summary Overall toxicity as assessed by NCI CTCAE v3.0
Measured: 8 months
Overall survival
Assess Overall survival
Measured: 8 months
Time to disease progression
Assess Time to disease progression
Measured: 8 months
Duration of response
Assess Duration of response
Measured: 8 months
Time to treatment failure
Assess Time to treatment failure
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study start15 Jul 2006
- Primary completion3 Nov 2008
- Study completion3 Nov 2008
Why it stopped: Due to difficulty in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- In this non-randomized prospective trial, patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant were treated with carboplatin at a dose equivalent to an area under the concentration-time curve of 4.5 mg/ml.min on day 1 and gemcitabine 1500 mg/m2 on day 2 of every 2-week cycle. The primary end point was overall response rate.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Murray, MD, Study chair, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470249
- Sponsor's protocol ID
- CDR0000542627
- Other IDs
- 2005-005164-83, 2005
- Status last verified
- Jan 2021
- First submitted
- 3 May 2007
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Carboplatin in Combination With Gemcitabine as a Dose Dense Schedule in Patients With Locally Advanced or Metastatic Breast Cancer That Are Resistant to Anthracyclines & Taxanes
- ClinicalTrials.gov ID
- NCT00470249
- Acronym / sponsor ID
- CDR0000542627
- Conditions
- Breast Cancer
- Keywords
- stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, male breast cancer, stage IIIA breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulty in recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 15 Jul 2006 (actual)
- Primary completion
- 3 Nov 2008 (actual)
- Study completion
- 3 Nov 2008 (actual)
- First posted
- 7 May 2007 (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.
RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin together with gemcitabine works in treating patients with locally advanced or metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the overall response rate in patients with anthracycline- and taxane-resistant locally advanced or metastatic breast cancer treated with dose-dense carboplatin and gemcitabine hydrochloride.
Secondary
- Determine the overall toxicity of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
- Determine the time to disease progression in patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine the time to treatment failure in patients treated with this regimen.
OUTLINE: This is a nonrandomized, open-label study.
Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 150 minutes on day 2. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this non-randomized prospective trial, patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant were treated with carboplatin at a dose equivalent to an area under the concentration-time curve of 4.5 mg/ml.min on day 1 and gemcitabine 1500 mg/m2 on day 2 of every 2-week cycle. The primary end point was overall response rate.
| Arm | Type | Receives |
|---|---|---|
| Patients with (HER-2)-negative and anthracycline- and taxane-resistant | Experimental | Drug: Carboplatin, Drug: Gemcitabine HydrochloridePatients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- DISEASE CHARACTERISTICS: histologically confirmed breast cancer, locally advanced or metastatic disease, recurrent or refractory disease, histological or cytological confirmation required for recurrence in a solitary site
- Must have received prior anthracycline and taxane as neoadjuvant, adjuvant, or metastatic therapy
- At least 1 measurable site of disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Palpable disease allowed, Lesions that have been irradiated in the advanced setting cannot be included as sites of measurable disease
- No nonmeasurable disease only, including the following:
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 |
|---|---|---|
| CarboplatinAt a dose equivalent to an area under the concentration-time curve of 4.5 mg/ml.min on day 1 of every 2-week cycle | Drug | Patients with (HER-2)-negative and anthracycline- and taxane-resistant |
| Gemcitabine Hydrochloride1500 mg/m2 on day 2 of every 2-week cycle | Drug | Patients with (HER-2)-negative and anthracycline- and taxane-resistant |
Primary outcome
Overall response rate (complete or partial response)
Time frame: 8 months
Assess the Overall response rate (complete or partial response)
5 secondary outcomes
Overall toxicity as assessed by NCI CTCAE v3.0
Time frame: 8 months
Overall survival
Time frame: 8 months
Time to disease progression
Time frame: 8 months
Duration of response
Time frame: 8 months
Time to treatment failure
Time frame: 8 months
Results and safety
The study was stopped early (reason given: Due to difficulty in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Publication of the resultsLink provided by the sponsor.
- 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.
Nicholas Murray, MD study chair
University Hospital Southampton NHS Foundation Trust
3 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 Carboplatin and Gemcitabine Hydrochloride in people with Breast Cancer, run by University of Southampton at 3 sites in United Kingdom.
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 45 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: stopped early, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 was stopped early (reason given: Due to difficulty in recruitment). 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?
Overall response rate (complete or partial response) (time frame: 8 months). 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 1 Feb 2021.