Clinical trial NCT00509665: Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer
Official title: A Phase II Study of Gemcitabine in Combination With Doxorubicin for Patients With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
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
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2007-07-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Response Rate
timeFrame: Every 6 weeks from the time of initial treatment for up to 8 months
Secondary outcomes:
measure: Duration of Response
timeFrame: Every 6 weeks for up to 8 months
measure: Progression-free Survival
timeFrame: Through the end of follow up, for an average of 8 months
measure: Overall Survival
timeFrame: From the time of initial therapy until the time of death.
measure: Number of Patients Who Had Greater Than Grade 2 Toxicity
timeFrame: from time of initial treatment until end of study, an average of 6 months
measure: Correlation of Cytoxocity With Cell-cycle Arrest
timeFrame: prior to first dose of drug and every 6 weeks up to 6 months
measure: Correlation of Cytotoxicity With Apoptosis in Cancer Cells
timeFrame: prior to first dose of drug and every 6 weeks for up to 6 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Paul O'Brien
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.