UNRESECTABLE PANCREATIC CANCER
Conditions
Interventions
Product Name: WF10
Product Code: OXO-K993
Pharmaceutical Form: Solution for infusion
Current Sponsor code: OXO-K993
Other descriptive name: Stabilized Chlorite Solution
Concentration unit: mmol/l mill
Sponsors
DIMETHAID AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years (inclusive) 2. Resident of Heidelberg or sufficient transportation and/or accommodation means for the treatment plan to be applied in Heidelberg 3. Written informed consent 4. Confirmed diagnosis of pancreatic cancer: (a) based on histology/cytology examination of the primary tumor, or alternatively of a metastasis of the primary tumor, and (b) that is inoperative, as determined by CT or MRI scan evidence of local invasion or metastases 5. At least one measurable lesion =1 cm on CT or MRI, as defined according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 6. Karnofsky Performance Index =70 7. Willingness to return for regular follow-up visits 8. Willingness of a female subject with reproductive potential, or male subject with a female partner with reproductive potential, to practice a medically-approved method of contraception during the treatment phase and 6 months after the last dose of study medication 9. Adequate hematological, hepatic, and renal function as defined by the following laboratory criteria (determined =14 days prior to first dose of study medication): . Creatinine clearance >50 mL/min (Cockroft and Gault formula) · Hemoglobin =100.0 g/L · Leukocytes (total WBC) >3.0 x 109/L · Absolute neutrophil count =2.0 x 109/L · Platelet count =100 x 109/L · Serum bilirubin =3.0 x ULN · Hepatic aminotransferases (ALT, AST) =2.5 x ULN (or = 5 x ULN if liver metastases are present) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior surgical resection of the pancreas (an exploratory surgical procedure is allowed). [A subject should not be enrolled in this trial to receive consolidation chemotherapy following successful tumor resection or for local recurrence of previously resected pancreatic cancer.] Any other surgical procedure during the previous 3 weeks, with the exception of insertion of a port or other permanent intravenous catheter, or a hepatojejunostomy or gastrojejunostomy, if surgically recovered (at least 2 weeks post-op), with no post-op wound infection or bile leakage. 2. Any systemic infection during the previous 2 weeks 3. Any prior chemotherapy or other drug treatment for pancreatic cancer 4. Pregnant or lactating female 5. Other primary malignancy within the previous 5 years, except for carcinoma in situ of the uterine cervix or adequately treated basal cell carcinoma of the skin. 6. Participation in another clinical study within the previous 3 weeks 7. Inability to reliably absorb orally administered capecitabine including malabsorption syndrome, major resection of the stomach or proximal small bowel, or other disorder 8. Subject selection conflicts with warnings, precautions and contraindications stated in the current Summary of Product Characteristics for capecitabine (Xeloda®) 9. Concurrent use of aluminum- or magnesium hydroxide-containing antacid 10. Ongoing use of any chemotherapeutic agent (e.g. methotrexate for psoriasis), immune modulator (e.g. tumor necrosis factor-alpha [TNF-a] blocker for rheumatoid arthritis) or bone marrow stimulant (e.g. erythropoietin, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], etc.) 11. Any other concurrent disease or condition which, in the judgment of the investigator, would jeopardize the subject’s health or preclude accurate assessment of the effect of the investigational treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate the safety and efficacy of adjunctive therapy with WF10 when combined with capecitabine therapy in subjects with unresectable cancer of the pancreas. Efficacy will be measured by both objective measures, including growth of the tumor and subject survival, and subjective subject parameters of pain and overall well-being. Primary Efficacy Endpoint: Survival. Secondary Efficacy Endpoints :Tumor Response, Duration of Overall Tumor Response, Duration of Stable Disease (Time to Disease Progression). Other survival parameters to be evaluated include: 12-month survival and median overall survival, Tumor Marker CA19-9, Quality of Life, Pain Assessment and Immunological Assessment. ;Secondary Objective: Not Applicable;Primary end point(s): Survival at 6 months | — |
Countries
Germany
Outcome results
None listed