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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel | Experimental | One hour intravenous infusion on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consists of 49 days. Day 1 dose same level as last dose of original Study CA139-540 (100mg/m2, 80 mg/m2, or 60 mg/m2). Treatment to continue until disease progression or unacceptable toxicity apparent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weekly Day 1 to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel | Paclitaxel dosed at the same dose level as last dose received in original study (100 mg/m^2, 80 mg/m^2, or 60 mg/m^2) and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consisted of 49 days total. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only one participant enrolled in the study so all results represent one participant. | Posted | Number | adverse events | Weekly Day 1 to 4 years |
|
|
4 years (4 March 2008 to 24 March 2012)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paclitaxel | Paclitaxel dosed weekly (6 weeks on, 1 week off). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutrophil count decrease | Investigations | NCI-CTC version 2.0 | Non-systematic Assessment | 16 events were Grade 1, 26 events were Grade 2 and 2 events were Grade 3 |
Upon completion of Study CA139-540 (NCT 00344552), one subject (who had received 7 courses paclitaxel) rolled over into Study CA139-557. During four years in Study CA139-557, subject received an additional 30 courses of paclitaxel.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| C089957 | BMS 181339 |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Every 7 weeks Day 1 to 4 years |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
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| 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). | Only one participant enrolled so results are for one participant. | Posted | Number | participants | Every 7 weeks Day 1 to 4 years |
|
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| 0 |
| 1 |
| 1 |
| 1 |
|
| alopecia | Skin and subcutaneous tissue disorders | NCI-CTC version 2.0 | Non-systematic Assessment | 29 events were Grade 1; 1 event was Grade 2 |
|
| back pain | Musculoskeletal and connective tissue disorders | NCI-CTC version 2.0 | Non-systematic Assessment | 11 events were Grade 1; 2 events were Grade 2 |
|
| blood pressure increased | Investigations | NCI-CTC version 2.0 | Non-systematic Assessment | 1 event Grade 1 |
|
| chills | General disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 event |
|
| contusion | Injury, poisoning and procedural complications | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| cough | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| cystitis | Infections and infestations | NCI-CTC version 2.0 | Non-systematic Assessment | one event Grade 1; one event Grade 2 |
|
| decreased appetite | Metabolism and nutrition disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| dizziness | Nervous system disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| dry skin | Skin and subcutaneous tissue disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| dysgeusia | Nervous system disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 2 event |
|
| dysphagia | Gastrointestinal disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| eczema | Skin and subcutaneous tissue disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 event |
|
| fatigue | General disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| gingivitis | Gastrointestinal disorders | NCI-CTC version 2.0 | Non-systematic Assessment | one Grade 1 event; two Grade 2 events |
|
| glucose urine present | Investigations | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 2 events |
|
| hemoglobin decreased | Investigations | NCI-CTC version 2.0 | Non-systematic Assessment | One event Grade 1; 30 events Grade 2 |
|
| herpes zoster | Infections and infestations | NCI-CTC version 2.0 | Non-systematic Assessment | One Grade 1 event; one Grade 2 event |
|
| hypoesthesia | Nervous system disorders | NCI-CTC version 2.0 | Non-systematic Assessment | 29 Grade 1 events; 1 Grade 2 event |
|
| malaise | General disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Five were Grade 1 events; one event was Grade 2 |
|
| muscle spasm | Musculoskeletal and connective tissue disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| nasopharyngitis | Infections and infestations | NCI-CTC version 2.0 | Non-systematic Assessment | Five events were Grade 1; 2 events were Grade 2 |
|
| Nausea | Gastrointestinal disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| edema | General disorders | NCI-CTC version 2.0 | Non-systematic Assessment | 19 Grade 1 events; 9 Grade 2 events |
|
| periodontitis | Gastrointestinal disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 event |
|
| peripheral motor neuropathy | Nervous system disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| pharyngitis | Infections and infestations | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 2 event |
|
| protein urine present | Investigations | NCI-CTC version 2.0 | Non-systematic Assessment | One Grade 1 event; one Grade 2 event |
|
| pyrexia | General disorders | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| weight decreased | Investigations | NCI-CTC version 2.0 | Non-systematic Assessment | Grade 1 events |
|
| white blood cell count decreased | Investigations | NCI-CTC version 2.0 | Non-systematic Assessment | 11 Grade 1 events; 31 Grade 2 events |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |