Nab-paclitaxel and Gemcitabine Hydrochloride Followed by Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Brief summary public domain (ClinicalTrials.gov)

This phase II trial studies how well nab-paclitaxel and gemcitabine hydrochloride followed by radiation therapy before surgery work in treating patients with pancreatic cancer that can be removed by surgery. Chemotherapy drugs, such as nab-paclitaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving nab-paclitaxel, gemcitabine hydrochloride, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVE: I. To determine the R0 (complete resection) resection rate for subjects with borderline resectable or lymph node positive pancreatic adenocarcinoma treated with a multimodality neoadjuvant therapy of preoperative gemcitabine (gemcitabine hydrochloride) and ABRAXANE (nab-paclitaxel) followed by 5-fluorouracil (fluorouracil) based image-guided intensity-modulated radiation therapy (IG-IMRT) chemoradiotherapy. SECONDARY OBJECTIVES: I. To determine 1-year relapse-free survival rate with the investigational protocol. II. To determine 1-year and 2-year overall survival rates. III. To assess response rate by imaging (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) and pathologic analysis. IV. To assess the toxicity and safety according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) criteria. OUTLINE: PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel intravenously (IV) over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for 1 year.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment [At the time of surgery]. Number, percentage of participants (95% Confidence Interval). Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 42 (20 to 67). Analysis, Treatment (Chemotherapy, Chemoradiation Therapy, Surgery): binomial 42 (95% CI 20 to 67); p=.404; 2-sided exact binomial; superiority.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 [From the first dose of study drug(s) until 28 days after last study intervention, up to approximately 3 years, 10 months]. Number, Adverse Events. Blood and Lymphatic system disorders: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 4. Gastrointestinal disorders: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 24. Hepatobiliary disorders: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 1. Infections and infestations: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 3. Investigations: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 13. Metabolism and nutrition disorders: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 6. Musculoskeletal and connective tissue disorders: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 9. Nervous system disorders: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 15. Psychiatric disorders: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 2. Respiratory, thoracic and mediastinal disorders: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 7. Skin and subcutaneous tissue disorders: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 19. Vascular disorders: Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 3.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival Rate Defined as the Percentage of Subjects Alive at the 2 Year Time Point [From first dose of study drug until 2 years or time of death by any cause, which ever comes first. Participants are assessed every 3 months after completing study interventions.]. Number, percentage of participants (95% Confidence Interval). Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 41 (24 to 71).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival Rate Defined as the Percentage of Subjects Alive at the One Year Time Point [From first dose of study drug until 1 year or time of death by any cause, whichever comes first. Participants are assessed every 3 months after completing study interventions.]. Number, percentage of participants (95% Confidence Interval). Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 79 (63 to 100).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Relapse-free Survival Rate Defined as the Percentage of Subjects Who Are Without Recurrence or Death at One Year From Surgical Resection of the Primary Tumor [From time of resection until progression or death by any cause, within 1 year of resection. Participants are assessed by imaging every 3 months after completing study interventions.]. Number, percentage of participants (95% Confidence Interval). Resection (n=11): 64 (41 to 99).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Defined as the Percent of Subjects With Complete or Partial Disease Response as Confirmed Through Tumor Imaging With Computed Tomography (CT) [From first dose of study drug(s), with assessments at Staging 1 (approximately 2 months) and Staging 2 (approximately 5 months after first dose of study drug(s)).]. Number, percentage of participants (95% Confidence Interval). Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) (n=19): 21 (6 to 46).