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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

Page last updated: August 23, 2015

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