Trial Outcomes & Findings for Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer (NCT NCT00971841)

Last Updated: 2013-07-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Weekly Day 1 to 4 years

Results posted on

2013-07-26

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paclitaxel n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	47 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Japan	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Weekly Day 1 to 4 years

Population: Only one participant enrolled in the study so all results represent one participant.

Outcome measures

Outcome measures
Measure	Paclitaxel n=1 Participants Paclitaxel dosed weekly (6 weeks on, 1 week off).
Number of Adverse Events (AEs) Per Participant	32 adverse events

SECONDARY outcome

Timeframe: Every 7 weeks Day 1 to 4 years

Population: Only one participant enrolled so results are for one participant.

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).

Outcome measures

Outcome measures
Measure	Paclitaxel n=1 Participants Paclitaxel dosed weekly (6 weeks on, 1 week off).
Number of Participants With Complete Response to Tumor	1 participants

Adverse Events

Paclitaxel

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Paclitaxel n=1 participants at risk Paclitaxel dosed weekly (6 weeks on, 1 week off).
Investigations neutrophil count decrease	100.0% 1/1 • Number of events 44 • 4 years (4 March 2008 to 24 March 2012)
Skin and subcutaneous tissue disorders alopecia	100.0% 1/1 • Number of events 30 • 4 years (4 March 2008 to 24 March 2012)
Musculoskeletal and connective tissue disorders back pain	100.0% 1/1 • Number of events 13 • 4 years (4 March 2008 to 24 March 2012)
Investigations blood pressure increased	100.0% 1/1 • Number of events 1 • 4 years (4 March 2008 to 24 March 2012)
General disorders chills	100.0% 1/1 • Number of events 1 • 4 years (4 March 2008 to 24 March 2012)
Injury, poisoning and procedural complications contusion	100.0% 1/1 • Number of events 2 • 4 years (4 March 2008 to 24 March 2012)
Respiratory, thoracic and mediastinal disorders cough	100.0% 1/1 • Number of events 2 • 4 years (4 March 2008 to 24 March 2012)
Infections and infestations cystitis	100.0% 1/1 • Number of events 2 • 4 years (4 March 2008 to 24 March 2012)
Metabolism and nutrition disorders decreased appetite	100.0% 1/1 • Number of events 2 • 4 years (4 March 2008 to 24 March 2012)
Nervous system disorders dizziness	100.0% 1/1 • Number of events 11 • 4 years (4 March 2008 to 24 March 2012)
Skin and subcutaneous tissue disorders dry skin	100.0% 1/1 • Number of events 3 • 4 years (4 March 2008 to 24 March 2012)
Nervous system disorders dysgeusia	100.0% 1/1 • Number of events 1 • 4 years (4 March 2008 to 24 March 2012)
Gastrointestinal disorders dysphagia	100.0% 1/1 • Number of events 2 • 4 years (4 March 2008 to 24 March 2012)
Skin and subcutaneous tissue disorders eczema	100.0% 1/1 • Number of events 1 • 4 years (4 March 2008 to 24 March 2012)
General disorders fatigue	100.0% 1/1 • Number of events 2 • 4 years (4 March 2008 to 24 March 2012)
Gastrointestinal disorders gingivitis	100.0% 1/1 • Number of events 3 • 4 years (4 March 2008 to 24 March 2012)
Investigations glucose urine present	100.0% 1/1 • Number of events 2 • 4 years (4 March 2008 to 24 March 2012)
Investigations hemoglobin decreased	100.0% 1/1 • Number of events 31 • 4 years (4 March 2008 to 24 March 2012)
Infections and infestations herpes zoster	100.0% 1/1 • Number of events 2 • 4 years (4 March 2008 to 24 March 2012)
Nervous system disorders hypoesthesia	100.0% 1/1 • Number of events 30 • 4 years (4 March 2008 to 24 March 2012)
General disorders malaise	100.0% 1/1 • Number of events 6 • 4 years (4 March 2008 to 24 March 2012)
Musculoskeletal and connective tissue disorders muscle spasm	100.0% 1/1 • Number of events 12 • 4 years (4 March 2008 to 24 March 2012)
Infections and infestations nasopharyngitis	100.0% 1/1 • Number of events 7 • 4 years (4 March 2008 to 24 March 2012)
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 2 • 4 years (4 March 2008 to 24 March 2012)
General disorders edema	100.0% 1/1 • Number of events 28 • 4 years (4 March 2008 to 24 March 2012)
Gastrointestinal disorders periodontitis	100.0% 1/1 • Number of events 1 • 4 years (4 March 2008 to 24 March 2012)
Nervous system disorders peripheral motor neuropathy	100.0% 1/1 • Number of events 4 • 4 years (4 March 2008 to 24 March 2012)
Infections and infestations pharyngitis	100.0% 1/1 • Number of events 1 • 4 years (4 March 2008 to 24 March 2012)
Investigations protein urine present	100.0% 1/1 • Number of events 2 • 4 years (4 March 2008 to 24 March 2012)
General disorders pyrexia	100.0% 1/1 • Number of events 3 • 4 years (4 March 2008 to 24 March 2012)
Investigations weight decreased	100.0% 1/1 • Number of events 5 • 4 years (4 March 2008 to 24 March 2012)
Investigations white blood cell count decreased	100.0% 1/1 • Number of events 42 • 4 years (4 March 2008 to 24 March 2012)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER