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| ID | Type | Description | Link |
|---|---|---|---|
| MUSC-100838 |
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, 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 gemcitabine together with doxorubicin works in treating patients with recurrent or progressive head and neck cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine+doxorubicin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxorubicin hydrochloride | Drug | given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above. | Every 6 weeks from the time of initial treatment for up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Every 6 weeks for up to 8 months | |
| Progression-free Survival | Through the end of follow up, for an average of 8 months | |
| Overall Survival |
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DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically or cytologically confirmed head and neck cancer
Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
Must have received prior platinum-based chemotherapy regimen (cisplatin or carboplatin) with or without radiotherapy, unless the patient was deemed unsuitable for platinum-based therapy due to renal dysfunction or other clinical contraindication
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Not pregnant or breastfeeding
History of allergic reaction attributed to compounds of similar chemical or biological composition to gemcitabine hydrochloride or doxorubicin hydrochloride
Lower than normal cardiac ejection fraction
Uncontrolled intercurrent illness that would limit compliance with study requirements including, but not limited to, any of the following:
Clinical AIDS or known positive HIV serology
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul O'Brien | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21791630 | Result | Saddoughi SA, Garrett-Mayer E, Chaudhary U, O'Brien PE, Afrin LB, Day TA, Gillespie MB, Sharma AK, Wilhoit CS, Bostick R, Senkal CE, Hannun YA, Bielawski J, Simon GR, Shirai K, Ogretmen B. Results of a phase II trial of gemcitabine plus doxorubicin in patients with recurrent head and neck cancers: serum C(1)(8)-ceramide as a novel biomarker for monitoring response. Clin Cancer Res. 2011 Sep 15;17(18):6097-105. doi: 10.1158/1078-0432.CCR-11-0930. Epub 2011 Jul 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine+Doxorubicin | doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine+Doxorubicin | doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle |
| 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 | Response Rate | Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above. | patients who were on study at the time of response assessment | Posted | Number | participants | Every 6 weeks from the time of initial treatment for up to 8 months |
|
Prior to each cycle while on treatment for an average of 6 months
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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 | Gemcitabine+Doxorubicin | doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Anderton | Medical University of South Carolina | 843-792-2708 | anderton@musc.edu |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D018304 | Esthesioneuroblastoma, Olfactory |
| D012468 | Salivary Gland Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| gemcitabine hydrochloride | Drug | given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle |
|
| From the time of initial therapy until the time of death. |
| Number of Patients Who Had Greater Than Grade 2 Toxicity | from time of initial treatment until end of study, an average of 6 months |
| Correlation of Cytoxocity With Cell-cycle Arrest | prior to first dose of drug and every 6 weeks up to 6 months |
| Correlation of Cytotoxicity With Apoptosis in Cancer Cells | prior to first dose of drug and every 6 weeks for up to 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Duration of Response | data for this endpoint was not collected | Posted | Every 6 weeks for up to 8 months |
|
|
| Secondary | Progression-free Survival | Only patients who had re-staging scans are included in the number of participants analyzed. | Posted | Median | 95% Confidence Interval | months | Through the end of follow up, for an average of 8 months |
|
|
|
| Secondary | Overall Survival | Posted | Median | 95% Confidence Interval | Months | From the time of initial therapy until the time of death. |
|
|
|
| Secondary | Number of Patients Who Had Greater Than Grade 2 Toxicity | Patients who were treated on study and had greater than grade 2 toxicity. | Posted | Count of Participants | Participants | from time of initial treatment until end of study, an average of 6 months |
|
|
|
| Secondary | Correlation of Cytoxocity With Cell-cycle Arrest | data for this endpoint was not collected | Posted | prior to first dose of drug and every 6 weeks up to 6 months |
|
|
| Secondary | Correlation of Cytotoxicity With Apoptosis in Cancer Cells | Data for this endpoint was not collected | Posted | prior to first dose of drug and every 6 weeks for up to 6 months |
|
|
| 1 |
| 18 |
| 18 |
| 18 |
| neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| vomitting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| DVT | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009447 | Neuroblastoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D020431 | Olfactory Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |