Phase 2
N=14
Depsipeptide in Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Stage IV Squamous Cell Carcinoma of the Hypopharynx · Stage IV Squamous Cell Carcinoma of the Larynx · Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity · Stage IV Squamous Cell Carcinoma of the Oropharynx
Bottom Line
View on ClinicalTrials.gov: NCT00084682 ↗Enrolled (actual)
14
Serious AEs
85.7%
Results posted
May 2015
Primary outcome: Primary: Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease) — 2; 9; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- romidepsin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease) |
2; 9; 2 | — |
| SECONDARY Duration of Response |
— | — |
| SECONDARY Time to Progression |
— | — |
| SECONDARY Overall Survival |
— | — |
Summary
This phase II trial is studying how well FR901228 works in treating patients with unresectable recurrent or metastatic squamous cell carcinoma (cancer) of the head and neck. Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from dividing so they stop growing or die.
Eligibility Criteria
Inclusion Criteria
- histologically or cytologically confirmed squamous cell cancer of the head and neck (MedDRA code 90002024), excluding nasopharyngeal primaries, which is unresectable or metastatic; the disease must be incurable with surgery or radiation therapy; the tumor should preferably be present at the primary site, and it must be accessible to planned biopsy methods
- Measurable disease by RECIST,
- May have received any number of prior systemic chemotherapy regimen for unresectable, recurrent or metastatic disease; if the only site of measurable disease is a previously irradiated area, the patient must have documented progressive disease or biopsy-proven residual carcinoma; persistent disease after radiotherapy must be biopsy-proven at least 8 weeks after the completion of radiotherapy
- Life expectancy of greater than 3 months
- Normal organ and marrow function as defined by the following labs performed = 3 beats in a row), QTc > 500 msec, or LVEF < 40%
- Patients may not be co-medicated with an agent that causes QTc prolongation; - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- Not pregnant or lactating
- History of HIV infection
Data sourced from ClinicalTrials.gov (NCT00084682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.