Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer (NCT00509665) | Clinical Trial Compass
CompletedPhase 2
Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer
United States18 participantsStarted 2005-06
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Response Rate
Timeframe: Every 6 weeks from the time of initial treatment for up to 8 months