Clinical trial · Interventional
Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma
GAIN-1 Study: Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma
NCT01470417CI-TRIAL-00068989GAIN-1completedPhase 2Results postedClinicalTrials.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)
This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Chemotherapy + ChemoRadiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
- interventionNames
- Drug: Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy and ChemoRadiotherapy
- description
- Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
- interventionNames
- Drug: Chemotherapy + ChemoRadiotherapy
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria:
* • Histologically or cytologically confirmed adenocarcinoma of the pancreas.
* Patients must have locally advanced pancreatic cancer, classified as either low-risk resectable (LR), high-risk resectable (HR) or borderline resectable (BR)
* Age between 18 and 90 years at the time of consent.
* Patients with biliary obstruction must have adequate drainage prior to starting treatment.
* Patients must have ≤ Grade I peripheral neuropathy (CTCAE v 4.0)
* Patients must have ≤ ECOG Performance status 2
* Pretreatment laboratory parameters:
* Absolute granulocyte/neutrophil count (AGC/ANC) ≥ 1.8 thou/mm3
* Platelet count ≥ 100,000/mm3
* Bilirubin \< 2 mg/dl
* ALT/SGPT \< 10x upper limit of normal
* Creatinine \< 3 mg/dl
* Calculated creatinine clearance (via Cockcroft-Gault) \> 30 mL/min
* Baseline CA 19-9 levels
* Signed study specific, IRB stamped informed consent
Exclusion Criteria:
* • Evidence of any distant metastasis including peritoneal seeding and/or malignant ascites
* Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment
* Prior treatment for pancreatic cancer
* Active, untreated infection
* Surgical resection of the tumor (not including biopsies)
* Other malignancy (except non-melanoma skin cancer) that has not been disease-free for at least 5 years.
* Pregnant and/or breast-feeding women, or patients (men and women) of child-producing potential not willing to use medically acceptable contraception while on treatment and for at least 3 months thereafter.
* Use of anti-epileptics (drugs such as phenytoin, phenobarbitol and carbamazepine)
* ECG abnormality with the following: QTC \>500, left bundle branch block or any other clinically significant finding that would interfere with protocol therapy.
* History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physicianReferences
Publications (0)
Data not yet available
No reference posted for this study.