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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-I-68005 |
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Due to low accrual
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RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and carboplatin, 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 doxorubicin hydrochloride liposome together with carboplatin works in treating patients with recurrent, stage III, or stage IV primary endometrial cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxorubicin and carboplatin | Experimental | Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | IV |
| |
| pegylated liposomal doxorubicin hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Response (Complete and Partial) | Response Rate | Every 28 days |
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DISEASE CHARACTERISTICS:
Histologically confirmed primary endometrial carcinoma meeting 1 of the following criteria:
Measurable disease
PATIENT CHARACTERISTICS:
GOG performance status 0-2
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL
Creatinine < 2.5 mg/dL OR creatinine clearance ≥ 60 mL/min
ALT and AST ≤ 1.5 times upper limit of normal (ULN) (3 times ULN in the presence of liver metastases)
Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases)
Total bilirubin ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases)
Not pregnant or nursing
Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA scan or ECHO
No history of severe hypersensitivity reaction to doxorubicin hydrochloride liposome
No other invasive malignancy (i.e., breast cancer) within the past 5 years except nonmelanoma skin cancer
No cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Shashikant B. Lele, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxorubicin and Carboplatin | Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1 carboplatin: IV pegylated liposomal doxorubicin hydrochloride: IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
IV |
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| COMPLETED |
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| NOT COMPLETED |
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|
All treated and eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxorubicin and Carboplatin | Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1 carboplatin: IV pegylated liposomal doxorubicin hydrochloride: IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Response (Complete and Partial) | Response Rate | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | Every 28 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxorubicin and Carboplatin | Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1 carboplatin: IV pegylated liposomal doxorubicin hydrochloride: IV | 2 | 9 | 8 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Septic shock | Infections and infestations | Systematic Assessment |
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| Blood creatinine increased | Investigations | Systematic Assessment |
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| White blood cell count decreased | Investigations | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Oedema peripheral | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Herpes simplex | Infections and infestations | Systematic Assessment |
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| Wound infection | Infections and infestations | Systematic Assessment |
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| Blood alkaline phosphatase | Investigations | Systematic Assessment |
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| Blood creatine increased | Investigations | Systematic Assessment |
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| Blood creatinine increased | Investigations | Systematic Assessment |
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| Blood urea increased | Investigations | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Vaginal burning sensation | Reproductive system and breast disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Stent placement | Surgical and medical procedures | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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Due to the study's early termination and inadequate number of patients, no patients were analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| >=65 years |
|