Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ortho Biotech, Inc. | INDUSTRY |
| Aventis Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM, provided patient still meets the eligibility laboratory and performance status criteria. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Doxorubicin | Experimental | Liposomal doxorubicin 40 mg/m2 by 1 hour IV infusion repeated every 28 days. |
|
| Docetaxel | Experimental | Weekly docetaxel 36 mg/m2 by 30 minute IV infusion on days 1, 8, and 15 of the 28 day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Doxorubicin | Drug | Liposomal Doxorubicin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks. | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. | PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred. | 18 Months |
Not provided
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Denise A. Yardley, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19933081 | Result | Yardley DA, Burris HA 3rd, Spigel DR, Clark BL, Vazquez E, Shipley D, Barton J, Thompson D, Montes I, Greco FA, Hainsworth JD. A phase II randomized crossover study of liposomal doxorubicin versus weekly docetaxel in the first-line treatment of women with metastatic breast cancer. Clin Breast Cancer. 2009 Nov;9(4):247-52. doi: 10.3816/CBC.2009.n.042. |
| Label | URL |
|---|---|
| Published article in Clinical Breast Cancer | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A -Liposomal Doxorubicin Then Docetaxel | Liposomal doxorubicin (Arm A) Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle. Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided patient still met the eligibility laboratory and performance status criteria. |
| FG001 | Arm B - Docetaxel Then Liposomal Doxorubicin | Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized Treatment |
| |||||||||||||
| Crossover Treatment |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A -Liposomal Doxorubicin Then Docetaxel | Liposomal doxorubicin (Arm A) Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle. Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks. | Patients who were removed from treatment before evaluation were not included in analysis | Posted | Number | 95% Confidence Interval | percentage of patients | 18 Months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A - Liposomal Doxorubicin Then Docetaxel | Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q28 days thru peripheral vein or central venous access. This will define one cycle. Patients demonstrating progression on Liposomal Doxorubicin were eligible for crossover to treatment on Docetaxel, provided patient still met the eligibility lab and performance status criteria. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John D. Hainsworth, MD | Sarah Cannon Research Institute | 615-329-7274 | jhainsworth@tnonc.com |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Docetaxel | Drug | Docetaxel |
|
|
| NOT COMPLETED |
|
| BG001 | Arm B - Docetaxel Then Liposomal Doxorubicin | Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Arm B - Docetaxel Then Liposomal Doxorubicin | Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria. |
|
|
| Secondary | Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. | PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred. | Posted | Median | 95% Confidence Interval | months | 18 Months |
|
|
|
| 18 |
| 50 |
| 21 |
| 50 |
| EG001 | Arm B - Docetaxel Then Liposomal Doxorubicin | Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8, and 15 followed by one week rest, administered on an every 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria. | 22 | 52 | 35 | 52 |
| Failure to Thrive | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Bone | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Subtrochanteric Fracture |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Liver Dysfunction | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment | Jaundice |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Abdominal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage - GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Superior Vena Cava Syndome | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Musculoskeletal | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Progressive Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diverticular Abscess | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| CNS Ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Cerebrovascular Accident (CVA) |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis/Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hand-Foot | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Arthralgia/Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |