Clinical trial · Interventional
Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer
A Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the First Line Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer
NCT01851174CI-TRIAL-00031573terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI Leaving Site
Summary
Brief summary (as posted)
To determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.
Conditions
Conditions (2)
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 Carcinoma Non-resectable | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Stage IV Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine and nab-Paclitaxel
- description
- Gemcitabine (1,000 mg/m\^2) administered intravenously on days 1 and 15, every 28 days nab-Paclitaxel (125 mg/m\^2) administered intravenously on days 1 and 15, every 28 days
- interventionNames
- Drug: Gemcitabine
- Drug: nab-Paclitaxel
Primary outcomes (1)
- measure
- Overall Survival Based on Toxicity Profile of Adverse Events.
- timeFrame
- One year
- description
- Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel
Secondary outcomes (1)
- measure
- Progression Free Survival Time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma. 2. Patient has one or more radiographically measurable tumor. 3. Patients may have received prior adjuvant chemotherapy or radiation therapy (RT). 4. Age ≥ 18 years. 5. Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study. 6. ECOG performance status 0 - 2 and an expected survival of at least 3 months. 7. Acceptable hematological parameters within 2 weeks of commencing study therapy as follows: * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Hemoglobin (Hgb) ≥ 9g/dl 8. Patients with adequate organ function as measured by: A. Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. B. Hepatic: Bilirubin ≤ 2.0 mg/ and ALT and AST ≤ 1.5x the upper limit of normal. C. Renal: Creatinine ≤ 1.5 mg/dl and no other chronic kidney disease. 9. Women must meet one of the following criteria: * Post-menopausal for at least one year * Surgically incapable of child-bearing * Utilizing a reliable form of contraception for the duration of study participation. Women of child-bearing potential must have a negative serum β-HCG within 7 days of study drug administration. Exclusion Criteria: 1. Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting. 2. Previous use of any chemotherapy or radiation therapy for metastatic disease. 3. Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart). 4. Other significant active or chronic infection. 5. History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia. 6. Pregnant or nursing females. 7. Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity. 8. Major surgery, other than diagnostic surgery within 4 weeks of study entry. 9. Patient requires a legal authorized representative for consenting.
References
Publications (0)
Data not yet available
No reference posted for this study.