Clinical trial · Interventional
S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
NCT00337129CI-TRIAL-00018934completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eribulin mesylate | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- eribulin mesylate
- description
- eribulin mesylate
- interventionNames
- Drug: eribulin mesylate
Primary outcomes (1)
- measure
- Response Probability (Confirmed Complete and Partial Responses)
- timeFrame
- Every 6 weeks until progression of disease up to a maximum of 3 years after registration
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.