Status:
TERMINATED
A Health Service Research Study to Investigate Survival of Metastatic Pancreatic Cancer Patients After Sequential Chemotherapy
Lead Sponsor:
AIO-Studien-gGmbH
Collaborating Sponsors:
Celgene
Conditions:
Metastatic Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of the study is to assess the efficacy of second and third line therapies (OFF vs. FOLFIRI) in a sequential cross-over design in patients pretreated with nab-paclitaxel/gemcitabine first line.
Detailed Description
Secondary objectives are assessment of safety and feasibility of the sequential cross-over treatment approach for advanced treatment lines in PDAC. 204 patients will be randomized into the treatments ...
Eligibility Criteria
Inclusion
- Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Age ≥ 18 years at time of study entry
- Unresectable adenocarcinoma of the pancreas previously treated in the palliative setting with gemcitabine and nabpaclitaxel (Abraxane®)
- Adequately documented recurrence and disease status after/under 1st line (Best response, duration of treatment, time to progression, preexisting PNP and other side effects)
- Radiologically confirmed disease progression during 1st-line therapy and measurable reference cancer site(s) as defined by RECIST1.1
- Randomization and start of 2nd-line treatment possible within 4 weeks after radiologically documented disease progression during 1st-line therapy
- ECOG performance status 0-2
- No prior radiotherapy
- Adequate blood count, liver-enzymes, and renal function:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (\> 1500 per mm3)
- Platelet count ≥ 100 x 109/L (\>100,000 per mm3)
- AST (SGOT)/ALT (SGPT) \< 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be \< 5x ULN
- Serum creatinine CL ≥ 60 mL/min calculations according to local standard
- Bilirubin \< 3 ULN
- Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥ 60 years old and no menses for ≥ 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Exclusion
- Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 3 months prior to study start)
- Preexisting polyneuropathy (PNP) ≥ grade 3 \[National Cancer Institute Common Toxicity Criteria grade 3 or 4 sensory or motor neuropathy\]
- Prior or concurrent malignancy (other than pancreatic cancer) which either progresses or requires active treatment. Exceptions are: basal cell cancer of the skin
- History of DPD deficiency
- Morbus Gilbert
- History of hypersensitivity to any of the study drugs or any of the constituents of the products
- Medication that is known to interfere with any of the agents applied in the trial
- Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year)
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
- Any medical condition that contraindicates dosing with any of the IMPs or constitutes a safety risk for the patient including but not limited to:
- chronic inflammatory bowel disease and/or bowel obstruction.
- active uncontrolled infection
- clinically significant bleeding or bleeding diathesis
- clinically significant stomatitis
- active ulceration of the gastrointestinal tract
- Previous enrollment or randomization in the present study (does not include screening failure)
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG
- Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts \[§ 40 Abs. 1 S. 3 Nr. 3a AMG\]
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2021
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03331640
Start Date
January 2 2018
End Date
September 13 2021
Last Update
January 11 2022
Active Locations (1)
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1
Praxis für Innere Medizin
Friedrichshafen, Germany