Nab-pacliatxel Plus Gemcitabine in Korean Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Launched by SAMSUNG MEDICAL CENTER · Apr 21, 2015

Keywords

ClinConnect Summary

Preclinical studies have demonstrated that nab-paclitaxel may play a role in sensitizing the tumor to chemotherapeutic agents and specifically increases the antitumor efficacy when combined with gemcitabine. While the mechanism of action for the synergy is unclear, preclinical studies have generated hypothetical models. One hypothesis is a remodeling and weakening of the stroma barrier, allowing the chemotherapeutic agents to have better access to the tumor cells. Weakening the tumor-stroma barrier is particularly important in cancer that is characterized by dense stroma, such as pancreatic...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (Islet cell neoplasms or neuroendocrine carcinomas are excluded)
• • 2. ≥ 18 years of age at the time of signing the informed consent document
• • 3. ECOG 0-1
• • 4. At least one measurable lesion according to recist v1.1
• • 5. No prior palliative chemotherapy for the treatment of metastatic pancreatic cancer (Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed if the treatment had been received at least 6 months before enroll).
• • 6. Adequate BM function: ANC ≥1.5 × 109/L; Platelet count ≥100,000/mm2 (100 × 109/L); Hb (Hb) ≥9 g/dL.
• • 7. Adequate liver and renal function (obtained ≤14 days prior to enroll): AST (SGOT), ALT (SGPT) ≤2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤5 × ULN is allowed; Total bilirubin 1.5 ≤ ULN; Serum creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73 m2
• • 8. Albumin level ≥ 3 g/dl
• • 9. Subjects should be asymptomatic for jaundice prior to Cycle 1 Day 1
• • 10. Subject with signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
• 11. Female of childbearing potential (FCBP) (defined as a sexually mature woman who (1) has not undergone hysterectomy \[the surgical removal of the uterus\] or bilateral oophorectomy \[the surgical removal of both ovaries\] or (2) has not been naturally postmenopausal for at least 24 consecutive months \[ie, has had menses at any time during the preceding 24 consecutive months\]) must:
• • Either commit to true abstinence or agree to the use of 2 physician-approved contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on IP; and for 3 months following the last dose of IP; and
• • Has a negative serum pregnancy test (β-hCG) result at screening
• • 12. Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy
• • 13. Subject able to adhere to the study visit schedule and other protocol requirements.
• Exclusion Criteria:
• • 1. Subject has known symptomatic brain metastases.
• • 2. History of malignancy in the last 5 years.
• • 3. Breast-feeding or pregnant female
• • 4. Patients with plastic biliary stent (Metal biliary stents are allowed.)
• • 5. Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• • 6. Subject has known historical or active infection with HIV, hepatitis B, or hepatitis C.
• • 7. Subject has undergone major surgery within 4 weeks prior to Cycle 1 Day 1 of treatment in this study.
• • 8. Subject who experienced a recent myocardial infarction, including severe/unstable angina pectoris, coronary/peripheral artery bypass graft, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, significant or uncontrolled cardiovascular disease CHF, and cerebrovascular accident or transient ischemic attack, or seizure disorder in the past year.
• • 9. Subject has a history of allergy or hypersensitivity to any of the study drugs
• • 10. Subjects with history of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
• • 11. Subjects with a history of interstitial lung disease
• • 12. Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the prostate (Gleason score ≤ 7), cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment).
• • 13. Patients has \> Grade 1 pre-existing peripheral neuropathy (per CTCAE)
• • 14. Subject has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity.
• • 15. Subject is enrolled in any other clinical protocol or investigational trial with an interventional agent or assessments that may interfere with study procedures.
• • 16. Subject is unwilling or unable to comply with study procedures
• • 17. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.