Clinical trial · Interventional
Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer
Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers
NCT00005997CI-TRIAL-00003542terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual for Cohort II
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| becatecarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
- timeFrame
- Patients are followed every 3 months.
Secondary outcomes (1)
- measure
- Assess the toxicity associated with this drug in this patient population.
- timeFrame
- Patients are followed every 3 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 patientsReferences
Publications (2)
- RESULTDowlati 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. PMID 19399502
- RESULTDowlati 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.