Pancreatic Cancer
Conditions
Keywords
Pancreas, cancer, metastatic, chemotherapy
Brief summary
Patient therapy is tailored according to the molecular profile of the patient's tumor.
Detailed description
This study is for patients with metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to determine whether molecularly tailored therapy can improve the effectiveness of standard chemotherapy combinations for patients with metastatic pancreatic cancer. A series of special tests will be performed on a sample of tumor, and based on the results subjects will be assigned to one of seven chemotherapy treatments, with each being the combination of two standard chemotherapies. Each of these combinations has been safely used in patients with pancreatic or other types of cancer. The purpose of this study is to to determine the ability to personalize therapy in this manner, and to determine how many patients a larger study would need. A second purpose is not to determine if one doublet is better than another. Rather, this second purpose is to show that for all patients enrolled in this protocol who have been assigned a doublet based on their tumor's molecular analysis (molecular tailoring), treatment response will be better than would be expected compared to patients who have been treated in the past with no molecular tailoring.
Interventions
DRUGGem-OX
DRUGGem-5FU
DRUGGem-Tax
DRUGModified FOLFOX-6
DRUGOx-Tax
DRUGFOLFIRI
DRUGTax-Iri
Sponsors
Georgetown University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven pancreatic adenocarcinoma with measurable disease * Biopsy accessible tumor deposits * ECOG performance status 0-2 * Age \>/= 18 years * Subjects with no brain metastases or history of previously treated brain metastases * Adequate hepatic, renal, and bone marrow function * Partial thromboplastin time must be \</= 1.5 x upper normal limit of institution's normal range and INR \< 1.5 * Life expectancy \> 12 weeks * Women of childbearing potential must have a negative seum pregnancy test within 14 days prior to initiation of treatment * Subject is capable of understanding and complying with parameters as outlines in the protocol and able to sign and date the consents
Exclusion criteria
* CNS metastases which do not meet criteria outlines in inclusion criteria * Active severe infection or known chronic infection with HIV or hepatitis B virus * Cardiovascular disease * Life threatening visceral disease or other severe concurrent disease * Women who are pregnant, breastfeeding, or women of childbearing potential not using dual forms of effective contraception * Anticipated patient survival under 3 months * Patients receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biological composition to gemcitabine, oxaliplatin, 5-FU, docetaxel or irinotecan * Uncontrolled intercurrent illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timing of biopsy and treatment | 1 year | The number of days from study entry to biopsy to molecular results to first dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimates for future trials | 1 year | objective response rate, proportions of patients with each molecular profile, timing of biopsy and therapy results, usefulness of molecular profile results and adverse events. |
| Clinical Benefit | 1 year | confirmed classification of stable disease, partial response, or complete response |
| Progression-free survival | 1 year | Time in days from study entry until progression or death |
Countries
United States
Outcome results
None listed