Status:
COMPLETED
S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 t...
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00337129
Start Date
May 1 2006
End Date
July 1 2011
Last Update
August 25 2015
Active Locations (139)
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1
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
2
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
4
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000