QYHJ Granules Versus Xeloda in Metastatic Pancreatic Cancer

A Prospective, Randomized, Open-label, Phase II Study of QYHJ Granules Versus Xeloda in the Second-line Treatment of Patients With Metastatic Pancreatic Cancer

Primary End Point:

- To compare the overall survival (OS) using QYHJ Granules or Xeloda as the second therapy in patients with metastatic pancreatic cancer.

Secondary End Points:

• Compare clinical efficacy by other measures including PFS,tumor response,and changes in quality of life (QOL) between these two groups.
• Examine the feasibility and assess the side effects of treatment using QYHJ Granules in patients with metastatic pancreatic cancer.

Study Overview

• Status: Unknown
• Conditions: Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: Xeloda; Drug: QYHJ Granules

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically/cytologically confirmed metastatic pancreatic adenocarcinoma.
• Patients have failed from the prior chemotherapy without Xeloda. Adjuvant chemotherapy containing Xeloda and 6 months before recruitment is included.
• Patients haven't taken QYHJ Granules before. Prior exposure to Traditional Chinese Medicine not based on QYHJ Formula is allowed provided that at least one week washout time is given prior to initiation of experimental treatment.
• ECOG performance status 0, 1 or 2.
• 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: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, ALT < 3 x normal, albumin >30g/L.
• Age ≥ 18.
• Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4 weeks washout time is given.
• 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.
• Subjects who have a life expectancy of at least 3 months.

Exclusion Criteria:

• ECOG performance status 3 or 4.
• Known central nervous system involvement and leptomeningeal disease.
• Previous Xeloda-based chemotherapy （except usage for Adjuvant chemotherapy and 6 months before recruitment）.
• Prior treatment with QYHJ Granules.
• Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV),unstable angina, myocardial infarction within the past six months, severe arrhythmia.
• Concurrent infection requiring intravenous antibiotics, active HIV infection/HIV disease, psychiatric disorders, drug abuse.
• Known allergies to the QYHJ or Xeloda.
• Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Men and women of childbearing potential not using effective means of contraception.
• Known other non-adenocarcinoma pathological type.
• Other primary tumour (including primary brain tumours) within the last 5 years prior to enrollment, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer.
• Inability to take oral medication, prior surgical procedures affecting absorption or unwilling to take the Traditional Chinese Medicine.
• Patiens who are suffering from diarrhea.
• Subjects with poor compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xeloda; Subjects will receive Xeloda until progression	Drug: Xeloda; Xeloda dose is calculated according to body surface area.The recommended dose is 1000 mg/m² administered orally twice daily (morning and evening; equivalent to 2000 mg/m² total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles; Other Names: Capecitabine
Experimental: QYHJ Granules; patients will receive QYHJ Granules until progression	Drug: QYHJ Granules; 1-4 bags bid , days 1-42, every 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival (OS)	up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression free survival（PFS）	up to 3 years
Tumor response（ORR、DCR）	up to 3 years
Clinical benefit rate （CBR）and QOL assessment	up to 3 years
Number of adverse events of QYHJ Formula	up to 3 years

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: zhen Chen, M.D., Fudan University; Study Director: lu ming Liu, M.D., Fudan University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: December 16, 2012
• First Submitted That Met QC Criteria: February 20, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: TCM-002