Pancreatic Cancer
Conditions
Keywords
GV1001
Brief summary
To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.
Detailed description
This study is designed as a phase III, prospective, randomized, open-label, multicenter clinical trial comparing GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in treating locally advanced and metastatic pancreatic cancer patients. Patients will be treated until disease progression and will be subject to follow-up until death. Patients will be randomized equally between the two arms: 1. Gemcitabine and Capecitabine 2. GV1001+ Gemcitabine and Capecitabine
Interventions
DRUGGV1001
At week 1, GV1001 will be administered intradermally on day 1, day 3 and day 5. This will be followed by a once weekly schedule for weeks 2, 3, 4 and 6. After that, GV1001 will be administered once monthly until withdrawal from trial treatment due to patient choice, intolerable toxicity or disease progression. GM-CSF will be used as an adjuvant, given 10-15 minutes prior to each administration of GV1001.
DRUGGemcitabine
Gemcitabine 1000 mg/m\^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.
DRUGCapecitabine
Capecitabine 830 mg/m\^2 will be orally given in the morning and evening (total dose of 1660 mg/m\^2) for 21 days followed by 7 days' rest.
Sponsors
Samsung Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 19 years 2. Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas. 3. Locally advanced or metastatic disease precluding curative surgical resection or patients who have relapsed following previously resected pancreatic cancer. 4. Contrast enhanced CT scan of the thorax, abdomen and pelvis within 28 days (and up to a maximum of 32 days) prior to commencing treatment. 5. Unidimensionally measurable disease (from CT scan) in accordance with the RECIST guidelines. 6. ECOG performance status 0, 1 or 2. 7. Adequate organ function as determined by the following laboratory values: * Platelets ≥100 x 10\^9 /L * WBC ≥ 3 x 10\^9 /L * ANC ≥1.5 x 10\^9 /L * Serum total bilirubin ≤ 2.0 mg/dL * CCr (Cockcroft & Gault) \> 50 mL/min 8. Life expectancy ≥ 90 days 9. Fully informed written consent given.
Exclusion criteria
1. Brain metastasis or meningeal carcinomatosis. 2. Clinically significant serious disease or organ system disease not currently controlled on present therapy. 3. Previous chemotherapy for locally advanced and metastatic disease. Previously adjuvant chemotherapy for resected pancreatic cancer will be permitted providing chemotherapy was completed more than 12 months previously. 4. Radiotherapy within the last 8 weeks prior to start of study treatment. 5. Concurrent malignancies or invasive cancers diagnosed within the past 5 years except for adequately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix or resected pancreatic cancer. 6. Medication which might affect immunocompetence e.g. chronic treatment with long term steroids or other immunosuppressant for an unrelated condition. Patients will be eligible if they have been receiving short term steroids for palliation of cancer related symptoms. 7. Administration of medicines from other clinical trials within 8 weeks from registration. 8. Pregnancy or breast feeding. 9. Uncontrolled angina pectoris. 10. Known malabsorption syndromes. 11. Patients with a known hypersensitivity to any of the investigational products or patients with a dihydropyrimidine dehydrogenase (DPD) deficiency. 12. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom. 13. Investigator's judgment against participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity according to the NCI CTCAE v4.03 | one year | — |
| Time to tumor progression (TTP) | one year | — |
| Objective response rate (ORR) | one year | Objective response rate assesses by CT scan (RECIST and irRC criteria). |
| Change in CA19-9 (Serum cancer antigen) over time | one year | Cancer antigen 19-9 (CA 19-9) is used to help differentiate between cancer of the pancreas and other conditions, as well as to monitor treatment response and recurrence. |
| Clinical response with eotaxin level (baseline of serum eotaxin level, pg/mL) | one year | — |
| Quality of Life using EORTC QLQ-C30 | up to one year | — |
| Quality of Life using EQ-5D-3L | up to one year | — |
| Clinical benefit response (CBR) | one year | — |
Countries
South Korea
Contacts
Primary ContactHanna Park
Backup ContactYoon Jin Lee
Outcome results
None listed