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

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00509665
First received: July 30, 2007
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: doxorubicin hydrochloride
Drug: gemcitabine hydrochloride
Other: laboratory biomarker analysis
Other: liquid chromatography
Other: mass spectrometry
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine in Combination With Doxorubicin for Patients With Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Response rate (complete and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median and 1-year survival [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 17
Study Start Date: June 2005
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509665

Locations
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Paul O'Brien Medical University of South Carolina
  More Information

Additional Information:
Publications:
Responsible Party: Paul O'Brien, Hollings Cancer Center at Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00509665     History of Changes
Other Study ID Numbers: CDR0000558049, MUSC-100838
Study First Received: July 30, 2007
Last Updated: April 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Doxorubicin
Gemcitabine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 24, 2014