Clinical trial · Interventional
Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer
A Phase II Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer
NCT00660140CI-TRIAL-00011747completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the activity of gemcitabine combined with carboplatin in the treatment of patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Carboplatin
- description
- Gemcitabine 1000 mg/m2 IV for 30 minutes on days 1 and 8 of 21 day cycle. Maximum of 9 cycles. Carboplatin AUC 5 IV for 1 hour on day 1 of 21 day cycle. Maximum of 9 cycles.
- interventionNames
- Drug: Gemcitabine
- Drug: Carboplatin
Primary outcomes (1)
- measure
- To determine the response rate and time to failure for patients treated with this regimen
- timeFrame
- Every 3 cycles for a maximum of 9 cycles
- description
- 1 cycle = 21 days
Secondary outcomes (4)
- measure
- To describe the toxicities associated with gemcitabine and carboplatin in patients with cholangiocarcinoma or gallbladder cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
1. Patients must have biopsy-proven locally-advanced, metastatic or recurrent adenocarcinoma of the biliary ducts or gallbladder.
2. Patients must have measurable disease.
3. Patients must be 18 years or older.
4. Patients must have a NCI CTC Performance Status of 0-2.
5. Patients must have a life expectancy of \>= 3 months.
6. Patients must not have any prior chemotherapy for metastatic disease. Prior adjuvant radiation therapy and chemotherapy with 5FU and/or gemcitabine is allowed.
7. At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
8. Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ.
9. Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.
10. Initial Required Laboratory Values:
* 1\. Absolute neutrophil count \>= 1,500/mm3, platelet count \>= 100,000/mm3, and hemoglobin \>= 9 g/dL.
* 2\. Serum creatinine should be \<= 2 mg/dL.
* 3\. Serum bilirubin should be \<= 3.0 mg/dL (biliary stents allowed).
* 4\. Serum transaminases should be \<= 5-fold the institutional upper limits.
11. Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
12. Patients must be able to sign an informed consent.References
Publications (1)
- DERIVEDWilliams KJ, Picus J, Trinkhaus K, Fournier CC, Suresh R, James JS, Tan BR. Gemcitabine with carboplatin for advanced biliary tract cancers: a phase II single institution study. HPB (Oxford). 2010 Aug;12(6):418-26. doi: 10.1111/j.1477-2574.2010.00197.x. PMID 20662793