Huachansu & Gemcitabine in Pancreatic Cancer

NCT00837239 | Completed Phase 2 DMC

• 1 other identifier: 2006-0948
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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:

1. 1.Examine the feasibility and safety of treatment using huachansu in combination with gemcitabine in patients with pancreatic cancer.
2. 2.Determine clinical efficacy by other measures including tumor response, 6-month survival, and changes in quality of life (QOL) in patients with pancreatic cancer.
3. 3.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.

Conditions

Pancreatic Cancer

Keywords

HuaChanSu; HCS; Gastrointestinal; Gastrointestinal Disease; Metastases; Cancer; Pancreatic cancer; Placebo; Gemcitabine; Gemcitabine Hydrocholoride; Gemzar; Fudan UniversityCancer Hospital

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival at 4 Months

  Number of participants without disease progression four months following treatment.

  4 Months

Secondary Outcomes (1)

• Median Overall Survival

  Up to 4 Years

Study Arms (2)

Gemcitabine + HuaChanSu

EXPERIMENTAL

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; Drug: HuaChanSu

Gemcitabine + Placebo

EXPERIMENTAL

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; Drug: Placebo

Interventions

Gemcitabine DRUG

1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle).

Also known as: Gemcitabine Hydrocholoride, Gemzar

Gemcitabine + HuaChanSu; Gemcitabine + Placebo

HuaChanSu DRUG

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).

Also known as: HCS

Gemcitabine + HuaChanSu

Placebo DRUG

500 ml saline only administered as a 2 hour infusion by central line.

Gemcitabine + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cancer Hospital Fudan University

Shanghai, China

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms; Gastrointestinal Diseases; Neoplasm Metastasis; Neoplasms

Interventions

Gemcitabine; huachansu

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Chris Garrett, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 5, 2009
• Study Start: June 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

CN (1)