A Phase 1 interventional study of Liposomal Doxorubicin and Seliciclib in Breast Cancer, sponsored by M.D. Anderson Cancer Center. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-26.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
The goal of this clinical research study is to find the highest tolerable dose of seliciclib that can be given in combination with liposomal doxorubicin to patients with metastatic breast cancer.
The Study Drugs:
Seliciclib is designed to stop cancer cells from dividing, which may cause them to die.
Doxorubicin is a chemotherapy drug that is designed to stop the growth of cancer cells, which may cause the cells to die. Liposomal doxorubicin is a redesigned version of doxorubicin. The drug, doxorubicin, is enclosed in a fat bubble called a liposome. This is designed to allow the drug to get into the tumor tissue better and to stay in the body for a longer time.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of seliciclib based on when you joined this study. Up to 6 dose levels of seliciclib will be tested. At least 2 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of seliciclib is found.
All participants will receive the same dose level of liposomal doxorubicin.
Drug Administration:
You will take seliciclib by mouth with a cup (8 ounces) of water twice a day on Days 1-3 of each 28-day study cycle. The 2 doses should be taken 12 hours apart. Seliciclib should be taken 1 hour before or 2 hours after a meal. If you miss a dose, it can be taken up to 2 hours after the scheduled time. If it has been more than 2 hours, the missed dose should not be taken. You should resume taking the study drug at the next normally scheduled time.
You will receive liposomal doxorubicin by vein over 2-3 hours on Day 4 of each cycle.
On Days 5-28 you will not receive any study drugs.
Study Visits:
At all study visits, you will be asked about any side effects you may be having and about any other drugs you may be taking.
On Day 1 of every cycle:
During Week 2 of Cycle 1:
-Blood (about 1-2 teaspoons) will be drawn for routine tests.
You will have an ECHO or MUGA scan at least every 4 cycles to check your heart function.
After every even-numbered cycles (Cycles 2, 4, 6 and so on), you will have either a CT or MRI scan to check the status of the disease.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
About 4-6 weeks after you have stopped receiving the study drugs, you will have an end-of-study visit. The following tests and procedures will be performed:
This is an investigational study. Seliciclib is not FDA-approved or commercially available. It is currently being used for research purposes only.
Liposomal doxorubicin is FDA-approved and commercially available for metastatic breast cancer. The use of these drugs together is investigational.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
Browse Breast Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
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Exclusion Criteria:
Doxil (Liposomal doxorubicin) 40 mg/m2 intravenous (IV) over 2 -3 hours on Day 4 and Seliciclib starting dose 200 mg orally twice a day on Days 1 - 3 of 28 day cycle
Drug: Liposomal Doxorubicin · Drug: Seliciclib
40 mg by vein administered over 2 -3 hours on Day 4 of a 28 day cycle.
Also known as: Doxil, Doxorubicin Hydrochloride (Liposomal)
Starting dose 200 mg by mouth twice daily on Days 1 - 3 of a 28 day cycle.
Number of Participants with a Dose Limiting Toxicity(DLT)
Dose-limiting toxicity (DLT) defined as NCI Common Toxicity Criteria (version 4.0): Grade 3 or 4 thrombocytopenia lasting \> 2 weeks; Grade 3 or 4 neutropenia lasting \>2 weeks; Febrile neutropenia; Grade 3 or 4 non-hematologic toxicity that lasts \> 72 hours despite appropriate medical management (excluding grade 3 fatigue); or Delay in administration of cycle 2 of therapy for \>2 weeks due to myelosuppression. DLT must be considered treatment related and occur during cycle 1 of therapy.
Time frame: Cycle 1 of therapy (28 days)
Number of Participants with Clinical Response
Disease response assessed using standard imaging techniques every two cycles. Response measured and defined using modified RECIST criterias of CR, PR or SD at 6 months where Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter of target lesions, taking as reference baseline sum longest diameter; and Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference smallest sum of longest diameter since treatment started.
Time frame: 6 months
No study locations are listed for this record.
This study is withdrawn, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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