Trial Outcomes & Findings for Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer (NCT NCT00354601)
NCT ID: NCT00354601
Last Updated: 2017-08-30
Results Overview
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
TERMINATED
PHASE2
2 participants
8 weeks
2017-08-30
Participant Flow
Patients enrolled 01/23/2006 to 03/16/2007 at which time the protocol was suspended for lack of funding
Participant milestones
| Measure |
Docetaxel and Capecitabine
Docetaxel and Capecitabine therapy per protocol
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Docetaxel and Capecitabine
Docetaxel and Capecitabine therapy per protocol
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
progression
|
1
|
Baseline Characteristics
Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel and Capecitabine
n=2 Participants
Docetaxel and Capecitabine therapy per protocol
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
60.15 years
STANDARD_DEVIATION 8.84 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: unable to measure due to failure to complete
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Evaluated every 8 weeks during treatmentPopulation: unable to analyze due to failure to complete treatment or study
Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)Population: tracked during incomplete treatment period
summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.
Outcome measures
| Measure |
Docetaxel and Capecitabine
n=2 Participants
Docetaxel and Capecitabine therapy per protocol
|
|---|---|
|
Number of Participants With Grade 3 or Higher Toxicity
|
1 participants
|
SECONDARY outcome
Timeframe: Pre-entry, day 1, treatment endPopulation: neither patient completed study
comparison of treatment end to pre entry and day 1 of each treatment cycle.
Outcome measures
Outcome data not reported
Adverse Events
Docetaxel and Capecitabine
Serious adverse events
| Measure |
Docetaxel and Capecitabine
Docetaxel and Capecitabine therapy per protocol
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
50.0%
1/2 • Number of events 1
|
Other adverse events
| Measure |
Docetaxel and Capecitabine
Docetaxel and Capecitabine therapy per protocol
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • Number of events 2
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
100.0%
2/2 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
100.0%
2/2 • Number of events 2
|
Additional Information
Doug Case Biostatistician
Wake Forest University Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place