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

June 13, 2018 updated by: Medical University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gemcitabine+doxorubicin
Drug: doxorubicin hydrochloride
given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.
Drug: gemcitabine hydrochloride
given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: Every 6 weeks from the time of initial treatment for up to 8 months
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 Outcome Measures

Outcome Measure
Time Frame
Duration of Response
Time Frame: Every 6 weeks for up to 8 months
Every 6 weeks for up to 8 months
Progression-free Survival
Time Frame: Through the end of follow up, for an average of 8 months
Through the end of follow up, for an average of 8 months
Overall Survival
Time Frame: From the time of initial therapy until the time of death.
From the time of initial therapy until the time of death.
Number of Patients Who Had Greater Than Grade 2 Toxicity
Time Frame: from time of initial treatment until end of study, an average of 6 months
from time of initial treatment until end of study, an average of 6 months
Correlation of Cytoxocity With Cell-cycle Arrest
Time Frame: prior to first dose of drug and every 6 weeks up to 6 months
prior to first dose of drug and every 6 weeks up to 6 months
Correlation of Cytotoxicity With Apoptosis in Cancer Cells
Time Frame: prior to first dose of drug and every 6 weeks for up to 6 months
prior to first dose of drug and every 6 weeks for up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Paul O'Brien, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 30, 2007

First Submitted That Met QC Criteria

July 30, 2007

First Posted (Estimate)

July 31, 2007

Study Record Updates

Last Update Posted (Actual)

July 12, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000558049
  • MUSC-100838

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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