Clinical trial · Interventional
Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy
Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy
- 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)
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with locally advanced or metastatic pancreatic cancer that did not respond to first-line therapy with gemcitabine.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abraxane
- description
- One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4.
- interventionNames
- Drug: Abraxane
Primary outcomes (1)
- measure
- Overall Survival Rate at 6 Months
- timeFrame
- 6 months
- description
- Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.
Secondary outcomes (5)
- measure
- Number of Participants Showing Complete or Partial Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have histologically confirmed, locally advanced (unresectable) or metastatic pancreatic cancer, and have failed first-line treatment with a gemcitabine-containing regimen. 2. Patients have to be 18 years-old or older 3. Able to give signed Informed consent 4. Adequate end-organ function with laboratory parameters as follows: * Neutrophils: 1.5 x10\^9/L or greater * Plts: 100 x10\^9/L or greater * Hemoglobin: ≥ 9.0g/dL * Serum Creatinine: ≤ 1.5mg/dL * Bilirubin: ≤ 1.5 times the upper limit of the normal range (ULN) * Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times ULN 5. Adequate contraception: For female (or male) patients, either post-menopausal, or for pre-menopausal surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study 6. Measurable or non-measurable disease by RECIST criteria 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 8. Patients must be at least 3 weeks from prior therapies and must have recovered from prior toxicity 9. Life expectancy greater than 3 months 10. Willing and able to comply with the protocol requirement. 11. Patients must not have any peripheral neuropathy equal or greater than grade 2 Exclusion Criteria: 1. Chemotherapy within 3 weeks prior to enrollment 2. Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment. 3. Any major surgery within 4 weeks prior to enrollment 4. Peripheral neuropathy equal to or greater than grade 2 5. Clinical AIDS or known positive HIV serology 6. Evidence of concurrent, clinically evident malignancy, except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years 7. Unstable angina 8. New York Heart Association (NYHA) Grade II or greater congestive heart failure 9. History of myocardial infarction within 3 months 10. History of stroke within 3 months 11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study 12. Pregnant (positive pregnancy test) or lactating 13. Inability to comply with study and/or follow-up procedures 14. Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible. 15. Participants cannot have been in another experimental drug study within 4 weeks of the first infusion of these study medications.
References
Publications (1)
- RESULTHosein PJ, de Lima Lopes G Jr, Pastorini VH, Gomez C, Macintyre J, Zayas G, Reis I, Montero AJ, Merchan JR, Rocha Lima CM. A phase II trial of nab-Paclitaxel as second-line therapy in patients with advanced pancreatic cancer. Am J Clin Oncol. 2013 Apr;36(2):151-6. doi: 10.1097/COC.0b013e3182436e8c. PMID 22307213