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A Phase II Study of Gemcitabine in Combination With Doxorubicin for Patients With Head and Neck Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase II Study of Gemcitabine in Combination With Doxorubicin for Patients With Head and Neck Cancer


OBJECTIVES:

Primary

- To determine the overall response rate (complete and partial response) produced by the
combination of gemcitabine hydrochloride and doxorubicin hydrochloride in patients with
recurrent or progressive head and neck cancer.

Secondary

- To describe the overall and progression-free survival of patients treated with the
chemotherapy combination.

- To describe the duration of response (complete and partial response) among patients who
attain a response.

- To evaluate the toxicity associated with the administration of the combination in
previously treated head and neck cancer patients.

- To establish a correlation of the cytotoxicity of these agents with cell cycle-arrest
and apoptosis in cancer cells, particularly involving the sphingolipid pathway.

OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes and doxorubicin
hydrochloride IV over 5-10 minutes on days 1 and 8. Treatment repeats every 3 weeks for at
least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and after every 2 courses for
correlative studies. Samples are analyzed for plasma/serum sphingosine-1-phosphate,
ceramide, and other markers of the apoptotic pathway via LC/MS.

After completion of study treatment, patients are followed every 6 months for up to 3 years.

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

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete and partial response)

Safety Issue:

No

Principal Investigator

Paul O'Brien

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Federal Government

Study ID:

CDR0000558049

NCT ID:

NCT00509665

Start Date:

June 2005

Completion Date:

May 2011

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms

Name

Location

Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425