Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer

Medical University of South Carolina (MUSC)

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: doxorubicin hydrochloride

Drug: gemcitabine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00509665

CDR0000558049

MUSC-100838

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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
- Patients must have an echocardiogram or MUGA scan prior to the use of study drugs
Uncontrolled intercurrent illness that would limit compliance with study requirements including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation
Clinical AIDS or known positive HIV serology

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

Recovered from prior therapy
At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
At least 30 days since prior experimental agents
At least 4 weeks since prior radiotherapy for palliation or for the primary tumor

Exclusion criteria:

Prior gemcitabine hydrochloride or doxorubicin hydrochloride
Concurrent hormones or other chemotherapeutic agents, except for steroids given for adrenal failure, hormones given for non-disease-related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic
Concurrent palliative radiotherapy
Other concurrent investigational or commercial agents or therapies