Study of S-1 as Second Line Treatment on Advanced Pancreatic Cancers (APC-S1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT01074996
First received: February 23, 2010
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

A randomized , open-label, multicenter, phase II study to compare the efficacy of S-1 and S-1 plus Leucovorin as second line treatment on gemcitabine-refractory patients with inoperable or advanced pancreatic cancers,investigate the correlation between efficacy and the expressions of thymidylate synthase, dihydropyrimidine dehydrogenase and orotate phosphoribosyltransferase


Condition Intervention Phase
Pancreatic Cancer
Drug: S-1
Drug: S-1 plus Leucovorin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized , Open-label, Multicenter, Phase II Study to Compare the Efficacy of S-1 and S-1 Plus Leucovorin as Second Line Treatment on Gemcitabine-refractory Patients With Inoperable or Advanced Pancreatic Cancers

Resource links provided by NLM:


Further study details as provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:

Primary Outcome Measures:
  • Progression Free Survival(PFS) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Assuming a 1.8 months median PFS in the S-1 arm, the study was designed to detect an improvement in PFS to 3.5 months in the S-1 plus Leucovorin arm, or 96% prolongation. The calculated number of PFS events needed to detect this difference with α (two-side) of 0.05 and power of 0.8 was 70. Assuming an average enrollment rate of 2.2 patients per month during planned 3-years study period, a total of eighty patients would be able to provide sufficient number of PFS events for the study at end of the study. However, a total of 90 patients were planned for the study, in consideration of comparison for safety and the overall survival between the two treatment groups.


Secondary Outcome Measures:
  • overall survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Tumor response rate [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • safety and tolerance [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 92
Study Start Date: February 2010
Estimated Study Completion Date: July 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: S-1,
Subjects will receive S-1 until progression
Drug: S-1
40-60mg bid , days 1-14, every 3 weeks
Experimental: S-1 plus Leucovorin
patients will receive S-1 plus Leucovorin until progression
Drug: S-1 plus Leucovorin
S-1 40-60mg bid, days 1-14 , every 3 weeks Leucovorin 25mg bid , days 1-14 , every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed inoperable or APC.
  2. Failure of one prior gemcitabine-based regimen was required,chemotherapy used as a radiation sensitizer in the adjuvant or locally advanced setting was not considered as a prior regimen. Patients received last adjuvant gemcitabine-based chemotherapy less than (or equal to) six months can be enrolled into this study.
  3. Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  4. Age ≥18 years old.
  5. ECOG performance status 0 or 1.
  6. Written informed consent and able to comply with the protocol.

Exclusion Criteria:

  1. Local (Stage IA to IIB) pancreatic cancer and locally advanced (stage III) pancreatic cancer. Patients relapsing with metastatic disease, after initial diagnoses with local disease can be enrolled into this study.
  2. Previous adjuvant radiotherapy for pancreatic cancer, except for patients with progressive lesions outside the radiation port who completed the radiotherapy at least 6 months prior to study entry.
  3. More than (or equal to) six months since last adjuvant chemotherapy. Adjuvant therapy without gemcitabine based adjuvant therapy is not allowed. Patient must have recovered from all treatment related toxicity prior to enrollment and must have documented evidence of disease progression (metastatic) following prior chemotherapy.
  4. No previous gemcitabine-based therapy for inoperable or APC.
  5. 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.
  6. Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases.
  7. History or evidence upon neurological exam of CNS disease (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures.
  8. Inability to take oral medication, prior surgical procedures affecting absorption or resulting in the requirement for intravenous alimentation or parenteral nutrition with lipids, and/or active peptic ulcer disease
  9. 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
  10. Men and women of childbearing potential (<2 years after last menstruation) not using effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
  11. Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study
  12. Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or patient at high risk from treatment complications
  13. Known hypersensitivity to any of the study drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074996

Locations
China, Beijing
307 Hospital of PLA
Beijing, Beijing, China, 100071
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
Principal Investigator: Xu jianming, M.D. The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
  More Information

No publications provided

Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT01074996     History of Changes
Other Study ID Numbers: APC-307PLAH-XJM
Study First Received: February 23, 2010
Last Updated: January 15, 2014
Health Authority: China: Ethics Committee

Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Pancreatic cancer
S-1
S-1 plus Leucovorin
second-line therapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Leucovorin
Levoleucovorin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on April 16, 2014