Trial Outcomes & Findings for Depsipeptide in Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (NCT NCT00084682)
NCT ID: NCT00084682
Last Updated: 2021-03-05
Results Overview
Tumor response was assessed every eight weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions as assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable disease (SD) was defined as having no evidence of response (CR or PR) as best response to therapy, and no evidence of disease progression (appearance of new lesions or \>/= 30% increase in target lesions) at 8 weeks.
COMPLETED
PHASE2
14 participants
Up to 2 years
2021-03-05
Participant Flow
A total of 14 patients were enrolled from one institution between June 2005 and October 2008
Participant milestones
| Measure |
Treatment (Romidepsin)
Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Romidepsin)
Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Depsipeptide in Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Treatment (Romidepsin)
n=14 Participants
Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
|
|---|---|
|
Age, Continuous
|
59.0 years
n=85 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=85 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=85 Participants
|
|
Race/Ethnicity, Customized
White
|
7 participants
n=85 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=85 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 participants
n=85 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsTumor response was assessed every eight weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions as assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable disease (SD) was defined as having no evidence of response (CR or PR) as best response to therapy, and no evidence of disease progression (appearance of new lesions or \>/= 30% increase in target lesions) at 8 weeks.
Outcome measures
| Measure |
Treatment (Romidepsin)
n=13 Participants
Patients receive FR901228 (depsipeptide) IV at 13 mg/m\^2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
|
|---|---|
|
Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease)
Symptomatic deterioration
|
2 participants
Interval 1.9 to 45.5
|
|
Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease)
Stable Disease
|
2 participants
Interval 1.9 to 45.5
|
|
Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease)
Disease progression
|
9 participants
Interval 1.9 to 45.5
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data not collected. As the first stage goal of 8 patients with disease control was not achievable, further analysis was not done.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data not collected. As the first stage goal of 8 patients with disease control was not achievable, further follow up was not done.
All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: data not collected
All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates. One and two-year survival and median survival time (if attained) will be estimated and reported with 95% confidence limits. If the sample sizes are sufficient, subgroup analysis based on baseline factors will be performed using the log rank test to compare survival curves.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Romidepsin)
Serious adverse events
| Measure |
Treatment (Romidepsin)
n=14 participants at risk
Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
2/14 • Number of events 14
|
|
Investigations
Thrombocytopenia
|
14.3%
2/14 • Number of events 2
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Fatigue
|
35.7%
5/14 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
2/14 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Number of events 2
|
|
Infections and infestations
Lung infection
|
21.4%
3/14 • Number of events 3
|
|
Infections and infestations
Soft tissue infection
|
7.1%
1/14 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
7.1%
1/14 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Romidepsin)
n=14 participants at risk
Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
|
|---|---|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
42.9%
6/14 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60