Overview

Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer

Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
All
Summary
To determine the activity of gemcitabine combined with carboplatin in the treatment of patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Washington University School of Medicine
Treatments:
Carboplatin
Gemcitabine
Criteria
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.