Esophageal Cancer
Conditions
Brief summary
The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced or recurrent esophageal cancer who have completed the previous Phase 2 study (CA139-540) and who should continue on therapy with paclitaxel as assessed by the treating investigator(s). To evaluate the severity of observed adverse reactions in treated subjects for assessment of long-term safety.
Interventions
DRUGPaclitaxel
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Subjects with advanced or recurrent esophageal cancer who have completed the previous late Phase 2 study (CA139-540) and for who continued therapy with paclitaxel would be beneficial as deemed by the investigator(s).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AEs) Per Participant | Weekly Day 1 to 4 years | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Severity of the adverse event was judged and graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Response to Tumor | Every 7 weeks Day 1 to 4 years | Tumor measured/evaluated via imaging and assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.0 wherein complete response is disappearance of all target lesions; partial response is 30% decrease in the sum of the longest diameter of target lesions; progressive disease is 20% increase in the sum of the longest diameter of target lesions, and stable disease is small changes that do not meet above criteria. The baseline assessment was done prior to the first administration of drug in the original Study CA139-540 (NCT 00344552). |
Participant flow
Recruitment details
Original Study CA139-540 (NCT 00344552) at Dr. K. Kato National Cancer Center Hospital in Tokyo, Japan, closed in 2008 and one participant rolled over into Study CA139-557.
Pre-assignment details
To be enrolled in Study CA139-557, participants with advanced or recurrent esophageal cancer must have completed original Study CA139-540 (NCT 00344552) and investigator(s) deemed that continuing treatment with paclitaxel would benefit the participant.
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel Paclitaxel dosed at the same dose level as last dose received in original Study CA139-540 (NCT 00344552)and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest. One treatment course consisted of 49 days total. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Paclitaxel |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age Continuous | 47 years |
| Region of Enrollment Japan | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Adverse Events (AEs) Per Participant
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Severity of the adverse event was judged and graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0.
Time frame: Weekly Day 1 to 4 years
Population: Only one participant enrolled in the study so all results represent one participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel | Number of Adverse Events (AEs) Per Participant | 32 adverse events |
Secondary
Number of Participants With Complete Response to Tumor
Tumor measured/evaluated via imaging and assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.0 wherein complete response is disappearance of all target lesions; partial response is 30% decrease in the sum of the longest diameter of target lesions; progressive disease is 20% increase in the sum of the longest diameter of target lesions, and stable disease is small changes that do not meet above criteria. The baseline assessment was done prior to the first administration of drug in the original Study CA139-540 (NCT 00344552).
Time frame: Every 7 weeks Day 1 to 4 years
Population: Only one participant enrolled so results are for one participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel | Number of Participants With Complete Response to Tumor | 1 participants |