Adult Primary Cholangiocellular CarcinomaPhase 2NCT00023946
BMS-247550 in Treating Patients With Liver or Gallbladder Cancer
A Phase 2 study testing ixabepilone and laboratory biomarker analysis in people with Adult Primary Cholangiocellular Carcinoma and Adult Primary Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of BMS-247550 in treating patients who have liver or gallbladder cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Primary Cholangiocellular Carcinoma, Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer
- What is being tested?
- ixabepilone and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced, metastatic, or recurrent hepatobiliary cancer
- Liver (hepatocellular)
- Bile duct (cholangiocarcinoma)
- Gallbladder
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
Show all 44Show fewer
- The following are not considered measurable lesions:
- Lesions seen on colonoscopic examination or barium studies
- Bone metastases
- CNS lesions
- Ascites
- No brain metastases
- Performance status - ECOG 0-2
- At least 3 months
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- AST/ALT no greater than 2.5 times upper limit of normal
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No grade 2 or greater peripheral neuropathy
- No other uncontrolled concurrent illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No prior allergic hypersensitivity reaction attributed to compounds containing Cremophor EL (e.g., paclitaxel or compounds of similar chemical or biological composition to BMS-247550)
- No other currently active malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer for which patient has completed therapy and is at less than 30% risk of relapse
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent immunotherapy
- No prior chemotherapy
- No other concurrent chemotherapy
- No concurrent hormonal therapy
- No concurrent therapeutic radiotherapy
- At least 30 days since prior investigational agents
- At least 7 days since prior cimetidine
- No concurrent cimetidine
- No other concurrent commercial or investigational anticancer agents or therapies
- No concurrent unconventional therapies, food, or vitamin supplements (e.g., St. John's Wort)
- No concurrent combination antiretroviral therapy for HIV-positive patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer
Phase II trial to study the effectiveness of BMS-247550 in treating patients who have liver or gallbladder cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the objective response rate of patients with hepatobiliary cancer treated with BMS-247550.
II. Determine the toxicity of this drug in these patients. III. Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks until disease progression
- Conditions
- Adult Primary Cholangiocellular Carcinoma, Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Localized Extrahepatic Bile Duct Cancer
- Being tested
- ixabepilone, laboratory biomarker analysis
- Medical subject headings
- Carcinoma, Hepatocellular, Bile Duct Neoplasms, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ixabepiloneDrug
Also called BMS-247550, epothilone B lactam, Ixempra
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ixabepilone) | Experimental | Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: ixabepilone; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (partial or complete response) evaluated by RECIST
A 10% response rate precludes further study whereas a 25% response rate would indicate that further study is warranted.
Measured: Up to 8 years
Frequency and extent of cytotoxic activity graded according to the NCI CTC Version 2.0
Measured: Up to 8 years
Time to disease progression
Will also be evaluated using the Kaplan-Meier estimator.
Measured: From the first day of treatment until the date PD or death is first reported, assessed up to 8 years
Overall survival
Will also be evaluated using the Kaplan-Meier estimator.
Measured: From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that PD is objectively documented, assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2001
- Primary completionJul 2005
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Primary Cholangiocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hedy Kindler, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023946
- Sponsor's protocol ID
- NCI-2012-02407
- Other IDs
- NCI-2012-02407, CDR0000068878, NCI-3656, UCCRC-11045, UC#11045A, 3656, P30CA014599, N01CM62201
- Status last verified
- Dec 2012
- First submitted
- 13 Sep 2001
- Last updated
- 14 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer
- ClinicalTrials.gov ID
- NCT00023946
- Acronym / sponsor ID
- NCI-2012-02407
- Conditions
- Adult Primary Cholangiocellular Carcinoma, Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Localized Extrahepatic Bile Duct Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2001
- Primary completion
- Jul 2005 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II trial to study the effectiveness of BMS-247550 in treating patients who have liver or gallbladder cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed description
PRIMARY OBJECTIVES:
- Determine the objective response rate of patients with hepatobiliary cancer treated with BMS-247550.
II. Determine the toxicity of this drug in these patients. III. Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks until disease progression
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ixabepilone) | Experimental | Drug: ixabepilone, Other: laboratory biomarker analysisPatients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (44 listed)
- Histologically or cytologically confirmed locally advanced, metastatic, or recurrent hepatobiliary cancer
- At least 1 unidimensionally measurable lesion
- No brain metastases
- Performance status - ECOG 0-2
- At least 3 months
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ixabepiloneAlso: BMS-247550, epothilone B lactam, IxempraGiven IV | Drug | Treatment (ixabepilone) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (ixabepilone) |
Primary outcome
Objective response rate (partial or complete response) evaluated by RECIST
Time frame: Up to 8 years
A 10% response rate precludes further study whereas a 25% response rate would indicate that further study is warranted.
Frequency and extent of cytotoxic activity graded according to the NCI CTC Version 2.0
Time frame: Up to 8 years
Time to disease progression
Time frame: From the first day of treatment until the date PD or death is first reported, assessed up to 8 years
Will also be evaluated using the Kaplan-Meier estimator.
Overall survival
Time frame: From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that PD is objectively documented, assessed up to 10 years
Will also be evaluated using the Kaplan-Meier estimator.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hedy Kindler principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ixabepilone and laboratory biomarker analysis in people with Adult Primary Cholangiocellular Carcinoma and Adult Primary Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 44 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (partial or complete response) evaluated by RECIST (time frame: Up to 8 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.