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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509665
• Other study ID #: CDR0000558049
• Secondary ID: MUSC-100838
• Status: Completed
• Phase: Phase 2
• Start date: June 2005
• Est. completion date: May 2011

Study information

• Verified date: June 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• doxorubicin hydrochloride
given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.
• gemcitabine hydrochloride
given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle

Locations

Country	Name	City	State
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 pat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above.	Every 6 weeks from the time of initial treatment for up to 8 months
Secondary	Duration of Response		Every 6 weeks for up to 8 months
Secondary	Progression-free Survival		Through the end of follow up, for an average of 8 months
Secondary	Overall Survival		From the time of initial therapy until the time of death.
Secondary	Number of Patients Who Had Greater Than Grade 2 Toxicity		from time of initial treatment until end of study, an average of 6 months
Secondary	Correlation of Cytoxocity With Cell-cycle Arrest		prior to first dose of drug and every 6 weeks up to 6 months
Secondary	Correlation of Cytotoxicity With Apoptosis in Cancer Cells		prior to first dose of drug and every 6 weeks for up to 6 months