Clinical trial · Interventional
Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer
A Phase II Study of Induction Consolidation and Maintenance Approach for Patients With Advanced Pancreatic Cancer
NCT01488552CI-TRIAL-00023549completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Investigators in the PCRT team have developed a therapeutic regimen which attacks both the tumor compartment and the stromal compartment of pancreatic cancer and induces complete responses in a small percentage of patients with advanced stage IV pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRINOX | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Immunohistochemistry (IHC) Analysis | Genetic | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
| mFOLFIRI | Drug | — | UNRESOLVED |
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine & Abraxane Pancreatic Cancer
- description
- Gemcitabine+Nab-paclitaxel, FOLFIRINOX, Immunohistochemistry (IHC) Analysis, Metformin and Folfiri
- interventionNames
- Drug: Gemcitabine
- Drug: nab-paclitaxel
- Drug: FOLFIRINOX
- Genetic: Immunohistochemistry (IHC) Analysis
- Drug: Metformin
- Drug: mFOLFIRI
Primary outcomes (1)
- measure
- Complete Response Rate
- timeFrame
- 1 yr.
- description
- The primary objectives of this study are to relentlessly pursue treatment for 34 individual patients with Stage IV pancreatic cancer to obtain: • The complete response rate (as defined by a complete metabolomic response (CMR) of SUV normalization from baseline, OR a complete response on CT scan using a modified RECIST criteria and CA 19-9 (or CA 125, CEA, or PAM4 if not expressers of CA 19-9) down to normal limits (from at least \> 2X ULN).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented Stage IV metastatic adenocarcinoma of the pancreas with measurable disease * Performance status ECOG 0 or 1 * Patients may not have received prior treatment for metastatic pancreatic adenocarcinoma except for receiving gemcitabine or 5FU as a radiosensitizer along with radiation therapy; or have received gemcitabine for adjuvant treatment if they have been off gemcitabine for \> 12 months * Adult (\>18 years of age) male or non-pregnant and non-lactating female * A negative serum pregnancy test (Beta-hCG) documented within 72 hours of the first administration of study drug in female patients of child-bearing potential * Agreement to use contraception considered adequate and appropriate by the investigator * The following blood counts at baseline: * ANC \>/= 1.5 x 109/L * Hgb \> 9g/dL * Platelets \>100 x 109/L * The following blood chemistry levels at baseline: * AST and ALT \</= 2.5 x upper limit of normal range (ULN) or \< 5.0 ULN if liver metastasis are present * Bilirubin \</= ULN * Serum creatinine within 1.5 x ULN * PT, INR within 1.5 x ULN unless on therapeutic doses of warfarin * Must have measurable disease outside the pancreas by RECIST criteria * No clinically significant abnormalities in urinalysis results * Voluntary agreement to participate in this study after being informed about the nature of the study including potential risks and benefits and having the ability to have questions addressed. The patient must sign and date the IRB approved Informed Consent Form (ICF) prior to participation in any study-related procedures Exclusion Criteria: * Has pancreatic islet cell neoplasms * Is pregnant or lactating * Has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * Known infection with HIV, Hepatitis B or Hepatitis C. * Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies (see section 4.4.9) * Has a serious medical risk factor(s) involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug. * Is unwilling or unable to comply with study procedures. * Is enrolled in any other investigational trial. Caution of observation for interstitial pneumonitis in patients prior to enrollment: Before enrollment, evaluate candidate patients fro familial, environmental or occupational exposure to opportunistic pathogens, and do not enroll those with a history of slowly progressive dyspnea and unproductive cough, or of conditions such as sarcoidosis, silicosis. idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
References
Publications (2)
- BACKGROUNDConroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923. PMID 21561347
- BACKGROUNDVon Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3. PMID 21969517