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

Completed · Phase 2

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT00509665

Run by

Medical University of South Carolina

People needed

18

Starts

2005-06-01

Expected to finish

2011-05-01

Last updated by the study team

2018-07-12

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hollings Cancer Center at Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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