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NCT00509665 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2018-07-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response Rate

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outcome · POSTED

Duration of Response

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Number of Patients Who Had Greater Than Grade 2 Toxicity

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outcome · POSTED

Correlation of Cytoxocity With Cell-cycle Arrest

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outcome · POSTED

Correlation of Cytotoxicity With Apoptosis in Cancer Cells

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: doxorubicin hydrochloride
    2. Drug: gemcitabine hydrochloride
    label
    Gemcitabine+doxorubicin
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Gemcitabine+doxorubicin
    description
    given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.
    name
    doxorubicin hydrochloride
    type
    DRUG
  2. arm Group Labels
    1. Gemcitabine+doxorubicin
    description
    given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
    name
    gemcitabine hydrochloride
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
18
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Response Rate
    time Frame
    Every 6 weeks from the time of initial treatment for up to 8 months
secondary Outcomes
  1. measure
    Duration of Response
    time Frame
    Every 6 weeks for up to 8 months
  2. measure
    Progression-free Survival
    time Frame
    Through the end of follow up, for an average of 8 months
  3. measure
    Overall Survival
    time Frame
    From the time of initial therapy until the time of death.
  4. measure
    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
  5. measure
    Correlation of Cytoxocity With Cell-cycle Arrest
    time Frame
    prior to first dose of drug and every 6 weeks up to 6 months
  6. measure
    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
Full study description
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.
Source references
references
  1. citation
    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.
    pmid
    21791630
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      query cond
      Metastatic Squamous Neck Cancer With Occult Primary
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    Preserved source evidence · Not medical advice