Status:
COMPLETED
Huachansu & Gemcitabine in Pancreatic Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This protocol is part of a larger grant funded by the NCI to create an international research center to study traditional Chinese medicine (TCM). All of the patients enrolled in this study will be tre...
Detailed Description
The Study Drugs: HuaChanSu is a substance used in China to treat different types of cancer. One of the major elements of the substance is bufalin, which is an ingredient that has been shown to block ...
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed unresectable (locally advanced or stage IV) pancreatic adenocarcinoma.
- Karnofsky Performance Status \> 60 (see Appendix H for definition)
- Measurable disease by RECIST criteria must be present. Bone scan abnormalities alone will not be accepted as measurable disease. Lytic lesions seen on plain radiographs will not be accepted as measurable disease but will be evaluated in conjunction with bone scan abnormalities. Pure blastic bone metastases will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease. Irradiated lesions are not considered measurable.
- Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
- Patients must have adequate organ functions reflected by the laboratory criteria below: Granulocytes \>1,500/uL; Hemoglobin \>/= 8.0 gm/dL; Platelets \> 100,000/uL; Serum creatinine \< 2.0 mg/dL; Bilirubin \< 1.5 mg/dL; SGPT \< 3 x normal; Alk Phos \< 3 x normal; Calcium \</=11.0 mg/dL
- Age \>/=18
- Patients must not have received any prior chemotherapy. Prior exposure to Traditional Chinese Medicine is allowed provided that at least one week washout time is given prior to initiation of experimental treatment.
- Concomitant bisphosphonates are allowed for patients with bone metastases.
- Patients with jaundice must have a biliary drainage decompression operation before recruitment.
- Ability to understand and the willingness to sign a written informed consent.
- Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4 weeks washout time is given.
Exclusion
- Known central nervous system involvement and leptomeningeal disease
- Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
- Known allergies to the huachansu or toad skin products.
- Concurrent infection requiring intravenous antibiotics.
- Pregnant or lactating women.
- Prior treatment with systemic chemotherapy.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00837239
Start Date
June 1 2007
End Date
July 1 2012
Last Update
July 12 2012
Active Locations (1)
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1
Cancer Hospital Fudan University
Shanghai, China