Huachansu & Gemcitabine in Pancreatic Cancer
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00837239
First received: February 3, 2009
Last updated: July 10, 2012
Last verified: July 2012
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Purpose
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 treated at the Cancer Hospital, Fudan University, our sister institution in Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002). The research nurses have received training at MDACC and will receive regular oversight by MDACC personnel.
Primary End Point:
1. Determine the efficacy of huachansu as measured by progression free survival at 4 months.
Secondary End Points:
- Examine the feasibility and safety of treatment using huachansu in combination with gemcitabine in patients with pancreatic cancer.
- Determine clinical efficacy by other measures including tumor response, 6-month survival, and changes in quality of life (QOL) in patients with pancreatic cancer.
- Monitor patient blood levels of the three main cardiac glycosides that are in huachansu (bufalin, cinobufagin, and resibufogenin). This information will provide evidence to delineate the role of these cardiac glycosides in antitumor activity.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: Gemcitabine Drug: HuaChanSu Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Placebo-controlled, Blinded Phase II Study of Huachansu & Gemcitabine in Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Progression Free Survival at 4 Months [ Time Frame: 4 Months ] [ Designated as safety issue: No ]Number of participants without disease progression four months following treatment.
Secondary Outcome Measures:
- Median Overall Survival [ Time Frame: Up to 4 Years ] [ Designated as safety issue: No ]Median participants overall survival defined as date of study entry until death, or censored to last known date of survival, reported in days.
| Enrollment: | 80 |
| Study Start Date: | June 2007 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gemcitabine + HuaChanSu
Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off + HuaChanSu 20 mL/m2 for total 500 mL given as a 2 hour infusion, 5 days a week for 3 weeks then one week off (28 Day Cycle).
|
Drug: Gemcitabine
1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle).
Other Names:
Drug: HuaChanSu
20 mL/m2 for total 500 mL given as a 2 hour infusion, 5 days a week for 3 weeks then one week off (28 Day Cycle).
Other Name: HCS
|
|
Experimental: Gemcitabine + Placebo
Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle) + Placebo 500 ml saline only administered as a 2 hour infusion by central line.
|
Drug: Gemcitabine
1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle).
Other Names:
Drug: Placebo
500 ml saline only administered as a 2 hour infusion by central line.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00837239 History of Changes |
| Other Study ID Numbers: | 2006-0948 |
| Study First Received: | February 3, 2009 |
| Last Updated: | July 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
HuaChanSu HCS Gastrointestinal Gastrointestinal Disease Metastases Cancer |
Pancreatic cancer Placebo Gemcitabine Gemcitabine Hydrocholoride Gemzar Fudan UniversityCancer Hospital |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013