QYHJ Granules Versus Xeloda in Metastatic Pancreatic Cancer
Information source: Fudan University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Pancreatic Cancer
Intervention: Xeloda (Drug); QYHJ Granules (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Fudan University Official(s) and/or principal investigator(s): zhen Chen, M.D., Principal Investigator, Affiliation: Shanghai Cancer Center, Fudan University lu ming Liu, M.D., Study Director, Affiliation: Shanghai Cancer Center, Fudan University
Summary
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.
Clinical Details
Official title: A Prospective, Randomized, Open-label, Phase II Study of QYHJ Granules Versus Xeloda in the Second-line Treatment of Patients With Metastatic Pancreatic Cancer
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: overall survival (OS)
Secondary outcome: Progression free survival(PFS)Tumor response(ORR、DCR) Clinical benefit rate (CBR)and QOL assessment Number of adverse events of QYHJ Formula
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: January 2013
Last updated: February 20, 2013
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