Head and Neck Cancer
Conditions
Keywords
recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, recurrent adenoid cystic carcinoma of the oral cavity, recurrent basal cell carcinoma of the lip, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent verrucous carcinoma of the oral cavity, recurrent metastatic squamous neck cancer with occult primary, recurrent lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, recurrent lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx
Brief summary
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.
Interventions
DRUGdoxorubicin hydrochloride
given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.
DRUGgemcitabine hydrochloride
given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically or cytologically confirmed head and neck cancer * Recurrent or progressive disease * 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
* Known brain metastases PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status (PS) ≤ 2 OR Karnofsky PS ≥ 60% * Absolute neutrophil count ≥ 1,500/μL * Platelets ≥ 100,000/µL * Total bilirubin ≤ 1.5 mg/dL * AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal * Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 30 mL/min * Females of reproductive potential must not plan on conceiving children during study treatment period and must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | Every 6 weeks from the time of initial treatment for up to 8 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Overall Survival | From the time of initial therapy until the time of death. |
| 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 |
| Correlation of Cytotoxicity With Apoptosis in Cancer Cells | prior to first dose of drug and every 6 weeks for up to 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Gemcitabine+Doxorubicin |
|---|---|
| Age, Continuous | 57 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 18 |
| serious Total, serious adverse events | 1 / 18 |
Outcome results
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.
Time frame: Every 6 weeks from the time of initial treatment for up to 8 months
Population: patients who were on study at the time of response assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine+Doxorubicin | Response Rate | 4 participants |
Secondary
Correlation of Cytotoxicity With Apoptosis in Cancer Cells
Time frame: prior to first dose of drug and every 6 weeks for up to 6 months
Population: Data for this endpoint was not collected
Secondary
Correlation of Cytoxocity With Cell-cycle Arrest
Time frame: prior to first dose of drug and every 6 weeks up to 6 months
Population: data for this endpoint was not collected
Secondary
Duration of Response
Time frame: Every 6 weeks for up to 8 months
Population: data for this endpoint was not collected
Secondary
Number of Patients Who Had Greater Than Grade 2 Toxicity
Time frame: from time of initial treatment until end of study, an average of 6 months
Population: Patients who were treated on study and had greater than grade 2 toxicity.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gemcitabine+Doxorubicin | Number of Patients Who Had Greater Than Grade 2 Toxicity | 10 Participants |
Secondary
Overall Survival
Time frame: From the time of initial therapy until the time of death.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine+Doxorubicin | Overall Survival | 5.6 Months |
Secondary
Progression-free Survival
Time frame: Through the end of follow up, for an average of 8 months
Population: Only patients who had re-staging scans are included in the number of participants analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine+Doxorubicin | Progression-free Survival | 1.6 months |