Esophageal CancerPhase 2NCT00971841
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer
A Phase 2 study testing Paclitaxel in people with Esophageal Cancer, run by Bristol-Myers Squibb.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Apr 2012
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
About this study
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.
- Conditions
- Esophageal Cancer
- Being tested
- Paclitaxel
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol, BMS-181339
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly Day 1 to 4 years
Secondary outcomes (1)
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).
Measured: Every 7 weeks Day 1 to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startMar 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971841
- Sponsor's protocol ID
- CA139-557
- Status last verified
- Jul 2013
- First submitted
- 3 Sep 2009
- Last updated
- 26 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes