NCT00337129 · REGISTRY CONDITION SEARCH

S0618 E7389 in Treating Patients With Metastatic or Recurrent 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: 2015-08-25

RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well E7389 works in treating patients with metastatic or recurrent 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 Probability (Confirmed Complete and Partial Responses)

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outcome · POSTED

Progression-Free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Participants With a Given Type of AE

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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: * Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) * Disease is either metastatic at diagnosis or has persisted, metastasized, or recurred after definitive surgery and/or radiotherapy * Not amenable to surgical resection for salvage therapy * No newly diagnosed nonmetastatic disease * No salivary or nasopharyngeal primary disease * Patients who have failed primary surgery alone, and who have disease that is salvageable by radiation or chemoradiation, are not eligible * Measurable disease * Measurable disease within a previous radiotherapy port must demonstrate clearly progressive disease * No active or prior CNS metastasis PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT and SGPT ≤ 2 times ULN * Creatinine ≤ 2 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception * No known HIV positivity * No prior malignancies except for the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Adequately treated stage I or II cancer currently in complete remission * Any other cancer for which the patient has been disease free for ≥ 5 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy for recurrent or newly diagnosed metastatic disease * At least 6 months since prior induction or adjuvant chemotherapy for patients who relapsed after receiving this therapy * No more than 1 prior induction or adjuvant regimen (may have included a taxane) * More than 2 weeks since prior biologic therapy (i.e., epidermal growth factor inhibitors and vascular endothelial growth factor inhibitors) * More than 28 days since prior radiotherapy and recovered * More than 28 days since prior surgery and recovered * No other concurrent therapy (i.e., radiotherapy, chemotherapy, immunotherapy, biologic therapy, or gene therapy) for SCCHN * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent prophylactic colony-stimulating factors during course 1
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
eribulin mesylate
intervention Names
Drug: eribulin mesylate
label
eribulin mesylate
type
EXPERIMENTAL

interventions

arm Group Labels
eribulin mesylate
description
1.4 mg/m2 by IV bolus on Days 1 and 8 of an every 21-day cycle.
name
eribulin mesylate
other Names
E7389
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 42
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.
measure
Response Probability (Confirmed Complete and Partial Responses)
time Frame
Every 6 weeks until progression of disease up to a maximum of 3 years after registration

secondary Outcomes

description
Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.
measure
Progression-Free Survival
time Frame
Every 6 weeks until progression of disease up to a maximum of 3 years after registration.
description
Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.
measure
Overall Survival
time Frame
Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration.
description
The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.
measure
Participants With a Given Type of AE
time Frame
Every 3 weeks while on protocol therapy, up to 3 years.

Full study description

brief Summary: RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well E7389 works in treating patients with metastatic or recurrent head and neck cancer.
detailed Description: OBJECTIVES: * Evaluate the response probability (confirmed, complete, and partial responses) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with E7389. * Estimate progression-free and overall survival probability in these patients. * Evaluate the qualitative and quantitative toxicities of this treatment regimen. OUTLINE: This is a multicenter study. Patients receive E7389 IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. After completion of study treatment, patients are followed periodically for up to 3 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice