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

NCT ID: NCT00509665

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2011-05-31

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine+doxorubicin

Group Type: EXPERIMENTAL

doxorubicin hydrochloride

Intervention Type: DRUG

given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.

gemcitabine hydrochloride

Intervention Type: DRUG

given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle

Interventions

doxorubicin hydrochloride

given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.

Intervention Type: DRUG

gemcitabine hydrochloride

given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• 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

• Known brain metastases

PATIENT CHARACTERISTICS:

• 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:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul O'Brien

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21791630 (View on PubMed)

Other Identifiers

MUSC-100838

Identifier Type: -

Identifier Source: secondary_id

CDR0000558049

Identifier Type: -

Identifier Source: org_study_id