Status:
COMPLETED
Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer
Lead Sponsor:
Washington University School of Medicine
Conditions:
Cholangiocarcinoma
Gallbladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To determine the activity of gemcitabine combined with carboplatin in the treatment of patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer.
Detailed Description
Due to better non-hematologic toxicity profile, less need for pre- and post chemotherapy hydration, and tolerability as compared to cisplatin, we propose to combine gemcitabine with carboplatin in the...
Eligibility Criteria
Inclusion
- Patients must have biopsy-proven locally-advanced, metastatic or recurrent adenocarcinoma of the biliary ducts or gallbladder.
- Patients must have measurable disease.
- Patients must be 18 years or older.
- Patients must have a NCI CTC Performance Status of 0-2.
- Patients must have a life expectancy of \>= 3 months.
- Patients must not have any prior chemotherapy for metastatic disease. Prior adjuvant radiation therapy and chemotherapy with 5FU and/or gemcitabine is allowed.
- At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
- Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ.
- 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.
- 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.
- Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
- Patients must be able to sign an informed consent.
Exclusion
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00660140
Start Date
March 1 2002
End Date
April 1 2009
Last Update
August 13 2013
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110