Scheduling nabpaclItaxel with gemcitabine (SIEGE)

Phase 2

Completed

• Conditions: Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Pancreas; Cancer; Malignant neoplasm of pancreas - Pancreatic duct

• Registration Number: ISRCTN71070888
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

2017 Abstract results in http://ascopubs.org/doi/10.1200/JCO.2017.35.4_suppl.342 results abstract, 2017 Gastrointestinal Cancers Symposium 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36813867/ Results (added 24/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-08
• Study Completion: 2015-07-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

1. Aged >= 18 years old
2. Signed informed consent and ability to comply with the protocol
3. Histologically or cytologically confirmed metastatic PDAC
4. Radiologically confirmed stage IV disease and measurable disease by RECIST version 1.1; baseline tumour assessments and measurements must be done within 28 days prior to randomisation
5. Karnofsky performance status =70%
6. Life expectancy >12 weeks from the date of screening assessment
Adequate bone marrow function
6.1. Absolute neutrophil count (ANC) =1.5 x 10^9 /L
6.2. Haemoglobin (Hb) = 100 g/L
6.3. Platelets =100 x 10^9 /L
6.4. White blood cell count (WBC) = 3 x 10^9 /L
7. Adequate liver function
7.1. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =2.5 x upper limit of normal range (ULN)
7.2. Total bilirubin <1.5 x ULN
8. Adequate renal function defined as a serum creatinine =1.5 x ULN or calculated creatinine clearance by CockcroftGaultv of =50 mL/min
9. Received no prior systemic therapy for metastatic disease
10. Prior adjuvant chemotherapy (with GEM or any other drug/s) is allowed if completed at least 6 months previously
11. Prior radiotherapy is allowed as long as there is measurable disease which has not been irradiated
12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, completion of QoL and HE questionnaires and other study procedures
13. Confirmation of tumour tissue sample collected within 12 weeks prior to randomisation and blood to be taken prior to randomisation
14. Women of childbearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not postmenopausal for at least 24 consecutive months if age =55 years or 12 months if age >55 years, must have a negative serum or urine pregnancy test within 14 days prior to randomisation
15. All WCBP, all sexually active male patients, and all partners of patients must agree to use effective contraception methods throughout the study and for 30 days after the final dose of study drug for WCBP and for up to 6 months after treatment for male patients

Exclusion Criteria

1. Patients with operable or locally advanced PDAC
2. Other invasive malignancies diagnosed within the last 5 years, except nonmelanoma
skin cancer and localized cured prostate cancer
3. Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality which in the judgment of the investigator would place the patient at undue risk or interfere with the trial. Examples include, but are not limited to:
3.1. Patients who have had a venous thromboembolic event who are not appropriately anticoagulated or have had a significant bleeding episode in the 3 weeks prior to randomisation
3.2. Patients with symptoms of severe chronic obstructive airways disease or significant shortness of breath at rest AND have an FEV1<1.0 L within the last 6 months
3.3. Patients with a history of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, cystic fibrosis or bronchiectasis
3.4. Patients with uncontrolled ischaemic heart or other cardiovascular event (myocardial infarction (MI), new angina, stroke transient ischaemic attack (TIA), or new congestive cardiac failure (CCF)) within the last 6 months
3.5. Patients with stable but significant cardiovascular disease defined by heart failure (New York Heart Association Functional Classification (NYHF) III or IV) or frequent angina
3.6. Presence of active infection
3.7. Cirrhotic liver disease, known chronic active or acute hepatitis B, or hepatitis C
3.8. Known allergy or hypersensitivity to GEM or ABX
4. Women who are pregnant, plan to become pregnant or are lactating
5. Use of oral antioxidant supplements: betacarotene, selenium, lutein, zeaxanthin, lycopene, pycnogenol, fernblock, omega3S, vitamin C, vitamin E, astaxanthin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival is calculated from the date of randomisation to the date of clinical/radiological progression or death from any cause, whichever occurs first