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Head and Neck CancerPhase 2NCT00509665

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

A Phase 2 study testing doxorubicin hydrochloride and gemcitabine hydrochloride in people with Head and Neck Cancer, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
doxorubicin hydrochloride and gemcitabine hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Jun 2005to May 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: 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.

Keywords
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
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esthesioneuroblastoma, Olfactory, Salivary Gland Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00509665
Study groupRoleWhat they receive
Gemcitabine+doxorubicinExperimentalNot described
Receives: Drug: doxorubicin hydrochloride; Drug: gemcitabine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Every 6 weeks from the time of initial treatment for up to 8 months

Secondary outcomes (6)

  1. Duration of Response

    Measured: Every 6 weeks for up to 8 months

  2. Progression-free Survival

    Measured: Through the end of follow up, for an average of 8 months

  3. Overall Survival

    Measured: From the time of initial therapy until the time of death.

  4. Number of Patients Who Had Greater Than Grade 2 Toxicity

    Measured: from time of initial treatment until end of study, an average of 6 months

  5. Correlation of Cytoxocity With Cell-cycle Arrest

    Measured: prior to first dose of drug and every 6 weeks up to 6 months

  6. Correlation of Cytotoxicity With Apoptosis in Cancer Cells

    Measured: prior to first dose of drug and every 6 weeks for up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2007 (estimated)
  2. Study startJun 2005
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00509665
Sponsor's protocol ID
CDR0000558049
Other IDs
MUSC-100838
Status last verified
Jun 2018
First submitted
30 Jul 2007
Last updated
12 Jul 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21791630

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing doxorubicin hydrochloride and gemcitabine hydrochloride in people with Head and Neck Cancer, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: Every 6 weeks from the time of initial treatment for up to 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00509665, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018; AzTrials last refreshed its copy on 26 Oct 2026.

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