Doxorubicin Hydrochloride Liposome and Bortezomib in Treating Patients With Refractory Hematologi… (NCT00237627) | Clinical Trial Compass
CompletedPhase 1/2
Doxorubicin Hydrochloride Liposome and Bortezomib in Treating Patients With Refractory Hematologic Cancer or Malignant Solid Tumor or Metastatic Breast Cancer
United States107 participantsStarted 2001-05
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving doxorubicin hydrochloride liposome together with bortezomib may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with doxorubicin hydrochloride liposome and to see how well they work in treating patients with refractory hematologic cancer or malignant solid tumor or metastatic breast cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
Phase I (closed to accrual as of 10/15/2007)
* Histologically or cytologically confirmed solid tumor or hematologic malignancy, including, but not limited to, any of the following:
* Breast cancer
* Ovarian cancer
* Myeloid or lymphoid leukemia
* Hodgkin or non-Hodgkin lymphoma
* Multiple myeloma
* Measurable or evaluable disease
* Must meet 1 of the following criteria:
* Refractory to at least one prior conventional treatment regimen
* Not a candidate for conventional therapy
* No conventional therapy exists
* No clinically or radiographically significant pleural or pericardial effusion
* Patients with ascites may be eligible at the discretion of the investigator
* Previously treated central nervous system disease allowed provided it has been stable for \> 3 months and it is not the only site of measurable disease
* Not eligible for a higher priority protocol
Phase II
* Diagnosis of breast cancer
* Metastatic disease
* Measurable disease by RECIST criteria
* No symptomatic brain metastases
* Patients with treated brain metastases that have been stable for \> 3 months and does not require chronic steroids are eligible
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Phase I (closed to accrual as of 10/15/2007)
* Karnofsky performance status 60-100%
* Life expectancy ≥ 2 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* WBC ≥ 2,000/mm³
* ANC…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) of PS-341 in combination with Doxil (Phase I)
Timeframe: 1 year
2
Response rate of the combination of Velcade and Doxil in patients with metastatic breast cancer