RAmucirumab Combined wIth Standard Nab-paclitaxel and Gemcitabine as First-line Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RACING (RAmucirumab Combined wIth standard Nab-paclitaxel and Gemcitabine as first-line chemotherapy in patients with advanced pancreatic adenocarcinoma) trial is a Greek, investigator-initiated, single-arm, open-label phase Ib-II study. Patients with advanced cytologically or histologically proven pancreatic adenocarcinoma will be treated with a combination of Ramucirumab with Nab-paclitaxel and Gemcitabine (for a maximum of 8 cycles followed by Ramucirumab maintenance) until disease progression or excessive Adverse Events (AEs) or Investigator's decision or patient's refusal of further treatment or death, whichever comes first.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Cooperative Oncology Group
• Collaborators: Celgene Corporation; Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel; Ramucirumab

Criteria

Inclusion Criteria:

1. Signed and dated written informed consent

2. Histologically or cytologically proven pancreatic adenocarcinoma.

3. Metastatic or locally advanced unresectable disease confirmed clinically/radiologically by CT-scan or MRI (Magnetic Resonance Imaging)

4. No prior therapy for metastatic disease.

5. At least one measurable or evaluable lesion as assessed by CT-scan or MRI according to RECIST v1.1

6. Age 18 years,

7. ECOG Performance status (PS) 0-1

8. The patient has adequate hepatic function as defined by a total bilirubin 1.5 mg/dL (25.65 μmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) 2.5 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases)

9. Female patients must commit to using reliable and appropriate methods of contraception during the trial until at least three months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another reliable contraceptive method during the trial until at least 6 months after the end of study treatment.

10. Patients must have a low or intermediate risk of arterial or venous thrombotic events (Khorana risk score 0-2). Patients at a high VTE risk (Khorana RS3) are eligible if they receive LMWH prophylaxis (Appendix D).

Exclusion Criteria:

1. The patient has pancreatic cancer with histology other than adenocarcinoma

2. Prior therapy for metastatic disease. Adjuvant Gemcitabine is permitted if 6 or more months have elapsed from last cycle to date of relapse.

3. Exclusive presence of bone metastasis only

4. Concomitant unplanned antitumor therapy

5. Treatment with any other investigational medicinal product within 28 days prior to study entry

6. Other serious and uncontrolled non-malignant chronic disease

7. The patient has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.

8. The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal antiinflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325mg/day) is permitted.

9. The patient has experienced grade 3-4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis within 3 months prior to first dose of protocol therapy.

10. Other concomitant or previous malignancy

11. The patient has symptomatic congestive heart failure (CHF; New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia

12. Bowel obstruction

13. The patient has a prior history of GI perforation/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation.

14. Palliative radiation therapy within 4 weeks prior to registration

15. The patient has a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to first dose of protocol therapy.

16. High risk for arterial or venous thrombotic complications as depicted by a Khorana Risk Score higher than 2 and inability to receive prophylaxis with low molecular weight heparin.