Metastatic Breast CancerPhase 2NCT00159094
A Trial of Doxil and Multiday Vinorelbine in Patients With Metastatic Breast Cancer
A Phase 2 study testing Doxil and Vinorelbine in people with Metastatic Breast Cancer, run by Hematology Oncology Consultants at 2 sites in United States.
Trial summary
This is a phase II trial of Doxil on day 1 and vinorelbine on days 1 and 2 in women with metastatic breast cancer. Administered every 28 days. A study to assess the safety and efficacy of Doxil and vinorelbine in metastatic breast cancer. 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?
- Doxil and Vinorelbine
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2003to not given
- 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
- Patients must be informed of the investigational nature of this study and must give and sign informed consent in compliance with federal and institutional guidelines.
- Women 18 years or older with biopsy proven advanced breast cancer.
- Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment.
- Performance status (PS) 0-2 (ECOG). PS must be 0-1 if patient has had more than one prior regimen for metastatic disease or more than 2 prior regimens, including adjuvant and metastatic.
- Measurable disease by RECIST criteria, with baseline staging completed within 14 days of registration.
- At least two weeks post surgery and three weeks from completion of irradiation and recovered from toxicities associated with these treatments.
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- Psychological, family, social and geographical conditions allowing weekly medical follow up during chemotherapy are required.
- Preregistration blood work must include complete blood counts with differential, and blood chemistries including serum bilirubin, GGT, LDH, SGOT, SGPT, alkaline phosphatase, creatinine, and tumor markers, CEA and CA 27-29. Patients must have:
- Absolute neutrophil count (ANC) >1,500/mm3
- Platelet count >100,000/mm3
- Hemoglobin > 8.0 g/dl
- Serum creatinine < 2.5 mg/dl (< 200 mol/L)
- Serum bilirubin < the upper limit of normal (ULN)
- SGOT and SGPT or AST and ALT < 2.0 x ULN
- Alkaline phosphatase < 2.0 x ULN, except if attributed to tumor
- Life expectancy > than 12 week.
Who cannot join
- Prior Doxil® or vinorelbine
- Cumulative anthracycline dose exceeding 400 mg/m2 anthracycline
- Primary anthracycline refractory disease, ie. disease progression during treatment or relapse/recurrence within 6 months after last dose of anthracycline
- If PS 0-1, more than 3 prior chemotherapy regimens, including adjuvant and metastatic
- If PS 2, more than 1 prior regimen for metastatic disease or more than 2 prior chemotherapy regimens, including adjuvant and metastatic
- Hormone therapy including aromatase inhibitors within 2 weeks of baseline
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- Pregnant or lactating women. Women of reproductive potential must have a negative pregnancy test and must agree to use an effective contraceptive method
- Prior history of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure
- Symptomatic brain metastasis
- Past medical history of severe hypersensitivity reaction to conventional formulation of doxorubicin HCL or the components of Doxil® or vinorelbine
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Hematology Oncology Consultants, Inc
Columbus, Ohio, 43235
Debbie Conover, RN, 614-846-0044 ext. 3104, debbie@hoci.org
Leslie R Laufman, MD
- Recruiting
Hematology Oncology Consultants, Inc
Newark, Ohio, 43055
Heather Meek, 740-344-5705 ext. 3312, heather@hoci.org
Leslie R Laufman, MD
About this study
Official title: A Phase II Trial of Doxil and Multiday Vinorelbine in Patients With Metastatic Breast Cancer
This is a phase II trial of Doxil on day 1 and vinorelbine on days 1 and 2 in women with metastatic breast cancer. Administered every 28 days. A study to assess the safety and efficacy of Doxil and vinorelbine in metastatic breast cancer.
Read the detailed description
PROTOCOL SUMMARY
Study design: Phase II trial of monthly Doxil® and vinorelbine on day 1 and 2 in women with metastatic breast cancer.
Treatment plan: Patients will continue therapy, until they have unacceptable toxicity or disease progression.
Primary endpoint: Response rate
Secondary endpoints: Time to progression, overall survival and toxicity.
Additional study objectives: Evaluation of treatment-related dyspnea, with measurement of pulse oximetry during and after drug administration, and rigorous study of patients who experience dyspnea. Palmar-plantar erythrodysesthesia (PPE) will be treated with one of 2 randomly assigned topical salves, measuring duration and severity of symptoms.
Eligibility: Women who have had prior chemotherapy in the adjuvant or metastatic setting, or both, up to 3 prior regimens. Patients having more than one prior regimen for metastatic disease must have a performance status of 0 or 1; others may have 0-2. No prior Doxil® or vinorelbine therapy. Patients are ineligible if prior anthracycline dose is greater than 400 mg/m2, or if they have primary anthracycline-refractory disease, with disease progression during treatment or with relapse/recurrence within 6 months after last dose of anthracycline. Patients must have normal neurologic, hematologic, renal and hepatic functional parameters. Asymptomatic brain metastases are permissible.
Treatment plan: Doxil® 40 mg/m2 IV infusion over 60 minutes on day 1 Vinorelbine 15 mg/m2 IV over 6 minutes on days 1 and 2 Dexamethasone 4 mg IV or 8 mg po (Doxil® pretreatment) Heparin 5000 U IV (Vinorelbine pretreatment) Pyridoxine (vitamin B6) 200 mg po qd Repeat every 28 days.
Supportive measures:
For anemia (hematocrit < 35): Procrit® 40,000 U q wk For neutropenia (ANC < 1,000/mm3 ): Prophylactic antibiotics (Cipro® or Septra®) For all cycles after neutropenic fever/infection or grade 3-4 stomatitis: Prophylactic Neulasta® 6 mg SQ on day 3 (This intervention may be adopted for all patients, all cycles, if 2 of the first 4 patients enrolled need it.) For PPE: randomize between 2 topical salves and document duration and severity of sx
Dose adjustments: Subsequent cycles are given on day 29 or after recovery or to grade 0-1 toxicity, with no more than 3 weeks delay. Reduce dose of both drugs by 25% if grade 3 or 4 stomatitis or palmar-plantar or grade 4 thrombocytopenia. Reduce dose of Doxil® ONLY by 50-75% if abnormal bilirubin, alkaline phosphatase and/or ALT, AST (appendix 14.3)
- Conditions
- Metastatic Breast Cancer
- Being tested
- Doxil and Vinorelbine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxil and VinorelbineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Secondary outcomes (3)
Time to progression
Overall survival
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2003
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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hematology Oncology Consultants
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Investigators
- Leslie R Laufman, MD, Principal investigator, Hematology Oncology Consultants, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159094
- Sponsor's protocol ID
- DO03-21-005
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 2 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Doxil and Multiday Vinorelbine in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00159094
- Acronym / sponsor ID
- DO03-21-005
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hematology Oncology ConsultantsUniversity, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Study start
- Oct 2003
- First posted
- 12 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 a phase II trial of Doxil on day 1 and vinorelbine on days 1 and 2 in women with metastatic breast cancer. Administered every 28 days. A study to assess the safety and efficacy of Doxil and vinorelbine in metastatic breast cancer.
Detailed description
PROTOCOL SUMMARY
Study design: Phase II trial of monthly Doxil® and vinorelbine on day 1 and 2 in women with metastatic breast cancer.
Treatment plan: Patients will continue therapy, until they have unacceptable toxicity or disease progression.
Primary endpoint: Response rate
Secondary endpoints: Time to progression, overall survival and toxicity.
Additional study objectives: Evaluation of treatment-related dyspnea, with measurement of pulse oximetry during and after drug administration, and rigorous study of patients who experience dyspnea. Palmar-plantar erythrodysesthesia (PPE) will be treated with one of 2 randomly assigned topical salves, measuring duration and severity of symptoms.
Eligibility: Women who have had prior chemotherapy in the adjuvant or metastatic setting, or both, up to 3 prior regimens. Patients having more than one prior regimen for metastatic disease must have a performance status of 0 or 1; others may have 0-2. No prior Doxil® or vinorelbine therapy. Patients are ineligible if prior anthracycline dose is greater than 400 mg/m2, or if they have primary anthracycline-refractory disease, with disease progression during treatment or with relapse/recurrence within 6 months after last dose of anthracycline. Patients must have normal neurologic, hematologic, renal and hepatic functional parameters. Asymptomatic brain metastases are permissible.
Treatment plan: Doxil® 40 mg/m2 IV infusion over 60 minutes on day 1 Vinorelbine 15 mg/m2 IV over 6 minutes on days 1 and 2 Dexamethasone 4 mg IV or 8 mg po (Doxil® pretreatment) Heparin 5000 U IV (Vinorelbine pretreatment) Pyridoxine (vitamin B6) 200 mg po qd Repeat every 28 days.
Supportive measures:
For anemia (hematocrit < 35): Procrit® 40,000 U q wk For neutropenia (ANC < 1,000/mm3 ): Prophylactic antibiotics (Cipro® or Septra®) For all cycles after neutropenic fever/infection or grade 3-4 stomatitis: Prophylactic Neulasta® 6 mg SQ on day 3 (This intervention may be adopted for all patients, all cycles, if 2 of the first 4 patients enrolled need it.) For PPE: randomize between 2 topical salves and document duration and severity of sx
Dose adjustments: Subsequent cycles are given on day 29 or after recovery or to grade 0-1 toxicity, with no more than 3 weeks delay. Reduce dose of both drugs by 25% if grade 3 or 4 stomatitis or palmar-plantar or grade 4 thrombocytopenia. Reduce dose of Doxil® ONLY by 50-75% if abnormal bilirubin, alkaline phosphatase and/or ALT, AST (appendix 14.3)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (16 listed)
- Patients must be informed of the investigational nature of this study and must give and sign informed consent in compliance with federal and institutional guidelines.
- Women 18 years or older with biopsy proven advanced breast cancer.
- Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment.
- Performance status (PS) 0-2 (ECOG). PS must be 0-1 if patient has had more than one prior regimen for metastatic disease or more than 2 prior regimens, including adjuvant and metastatic.
- Measurable disease by RECIST criteria, with baseline staging completed within 14 days of registration.
Key exclusion criteria (10 listed)
- Prior Doxil® or vinorelbine
- Cumulative anthracycline dose exceeding 400 mg/m2 anthracycline
- Primary anthracycline refractory disease, ie. disease progression during treatment or relapse/recurrence within 6 months after last dose of anthracycline
- If PS 0-1, more than 3 prior chemotherapy regimens, including adjuvant and metastatic
- If PS 2, more than 1 prior regimen for metastatic disease or more than 2 prior chemotherapy regimens, including adjuvant and metastatic
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 |
|---|---|---|
| Doxil and Vinorelbine | Drug | – |
Primary outcome
Response rate
3 secondary outcomes
Time to progression
Overall survival
Toxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2008.
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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.
Leslie R Laufman, MD principal investigator
Hematology Oncology Consultants, Inc
2 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 Doxil and Vinorelbine in people with Metastatic Breast Cancer, run by Hematology Oncology Consultants at 2 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 16 inclusion and 10 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 2 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Leslie R Laufman, MD (614-846-0044, email@hoci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate. 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 2 Jun 2008.