Extrahepatic Bile Duct CancerPhase 2NCT00005997
Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer
A Phase 2 study testing becatecarin in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have advanced liver and/or biliary cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
- What is being tested?
- becatecarin
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 1999to Nov 2005
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of advanced hepatobiliary carcinoma not amenable to conventional surgery
- Gall bladder carcinoma
- Cholangiocarcinoma
- Carcinoma of the ampulla
- Hepatocellular carcinoma (eligible for cohort II only)
- Measurable disease
- No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic:
- Bilirubin less than 3 mg/dL
- Cohort I (closed to accrual as of 11/1/03)
- Bilirubin no greater than 1.5 mg/dL
- AST no greater than 2.5 times upper limit of normal (ULN)
- Cohort II
- Bilirubin greater than 1.5 mg/dL and less than 3 mg/dL OR
- Bilirubin no greater 1.5 mg/dL AND AST greater than 2.5 times ULN
Renal:
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for cholangiocarcinoma or hepatobiliary carcinoma
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent combination antiviral therapy for HIV-positive patients
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have advanced liver and/or biliary cancer.
Read the detailed description
OBJECTIVES:
- Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
- Assess the toxicity associated with this drug in this patient population.
- Evaluate the survival of this patient population treated with this drug.
- Determine the pharmacokinetics of this drug in this patient population.
OUTLINE: This is a partial dose-escalation study.
Patients receive rebeccamycin analogue IV over 1 hour daily on days 1-5. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are assigned to 1 of 2 cohorts according to hepatic dysfunction. (Cohort I closed to accrual as of 11/1/03.)
- Cohort I (closed to accrual as of 11/1/03): Patients receive a fixed dose of rebeccamycin analogue.
- Cohort II: Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-37 months.
- Being tested
- becatecarin
- Keywords
- localized unresectable adult primary liver cancer, advanced adult primary liver cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, adult primary hepatocellular carcinoma, cholangiocarcinoma of the gallbladder, cholangiocarcinoma of the extrahepatic bile duct, adult primary cholangiocellular carcinoma
- Medical subject headings
- Bile Duct Neoplasms, Gallbladder Neoplasms, Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
becatecarinDrug
Also called DEAE-rebeccamycin, rebeccamycin analogue, rebeccamycin analogue, tartrate salt
Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
Measured: Patients are followed every 3 months.
Secondary outcomes (1)
Assess the toxicity associated with this drug in this patient population.
Measured: Patients are followed every 3 months.
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 startApr 1999
- Primary completionApr 2005
- Study completionNov 2005
Why it stopped: slow accrual for Cohort II
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Extrahepatic Bile Duct CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Afshin Dowlati, MD, Study chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005997
- Sponsor's protocol ID
- CWRU2299
- Other IDs
- U01CA063200, P30CA043703, CWRU-2299, NCI-96
- Status last verified
- Jun 2010
- First submitted
- 5 Jul 2000
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dowlati A, Posey J, Ramanathan RK, Rath L, Fu P, Chak A, Krishnamurthi S, Brell J, Ingalls S, Hoppel CL, Ivy P, Remick SC. Phase II and pharmacokinetic trial of rebeccamycin analog in advanced biliary cancers. Cancer Chemother Pharmacol. 2009 Dec;65(1):73-8. doi: 10.1007/s00280-009-1005-x. Epub 2009 Apr 28.
PubMed 19399502Dowlati A, Posey J, Ramanathan RK, et al.: Multicenter phase II and pharmacokinetic study of rebeccamycin analogue (RA) in advanced biliary cancers. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1070, 2003.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers
- ClinicalTrials.gov ID
- NCT00005997
- Acronym / sponsor ID
- CWRU2299
- Keywords
- localized unresectable adult primary liver cancer, advanced adult primary liver cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, adult primary hepatocellular carcinoma, cholangiocarcinoma of the gallbladder, cholangiocarcinoma of the extrahepatic bile duct, adult primary cholangiocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual for Cohort II
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1999
- Primary completion
- Apr 2005 (actual)
- Study completion
- Nov 2005 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have advanced liver and/or biliary cancer.
Detailed description
OBJECTIVES:
- Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
- Assess the toxicity associated with this drug in this patient population.
- Evaluate the survival of this patient population treated with this drug.
- Determine the pharmacokinetics of this drug in this patient population.
OUTLINE: This is a partial dose-escalation study.
Patients receive rebeccamycin analogue IV over 1 hour daily on days 1-5. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are assigned to 1 of 2 cohorts according to hepatic dysfunction. (Cohort I closed to accrual as of 11/1/03.)
- Cohort I (closed to accrual as of 11/1/03): Patients receive a fixed dose of rebeccamycin analogue.
- Cohort II: Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-37 months.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| becatecarinAlso: DEAE-rebeccamycin, rebeccamycin analogue, rebeccamycin analogue, tartrate saltCohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined. | Drug | – |
Primary outcome
Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
Time frame: Patients are followed every 3 months.
1 secondary outcome
Assess the toxicity associated with this drug in this patient population.
Time frame: Patients are followed every 3 months.
Results and safety
The study was stopped early (reason given: slow accrual for Cohort II). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2010.
- Results publication: PubMed 19399502Dowlati A, Posey J, Ramanathan RK, Rath L, Fu P, Chak A, Krishnamurthi S, Brell J, Ingalls S, Hoppel CL, Ivy P, Remick SC. Phase II and pharmacokinetic trial of rebeccamycin analog in advanced biliary cancers. Cancer Chemother Pharmacol. 2009 Dec;65(1):73-8. doi: 10.1007/s00280-009-1005-x. Epub 2009 Apr 28.
- Results publicationDowlati A, Posey J, Ramanathan RK, et al.: Multicenter phase II and pharmacokinetic study of rebeccamycin analogue (RA) in advanced biliary cancers. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1070, 2003.
Related trials for Extrahepatic Bile Duct Cancer
Recruiting
Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent for Unresectable Extrahepatic Cholangiocarcinoma
Extrahepatic Cholangiocarcinoma
RecruitingPhase 1/2
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Biliary Cancer, Bile Duct Cancer
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Biliary Tract Cancer
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
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.
Afshin Dowlati, MD study chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing becatecarin in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by Case Comprehensive Cancer Center at 3 sites 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?
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 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 (reason given: slow accrual for Cohort II). 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?
Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue. (time frame: Patients are followed every 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005997, which also lists 2 linked publications.
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 11 Jun 2010.