A Health Service Research Study to Investigate Survival of Metastatic Pancreatic Cancer Patients After Sequential Chemotherapy

NCT03331640 | Terminated Phase 2

• 1 other identifier: AIO-PAK-0116
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival during 2nd line therapy (PFS2)

  Progression-free survival time from randomization till progress during second line therapy.

  49 months

Study Arms (2)

OFF

EXPERIMENTAL

Drug: OFF

FOLFIRI

EXPERIMENTAL

Drug: FOLFIRI Protocol

Interventions

OFF DRUG

OFF: 5-FU 2000 mg/m2 as 24 hour infusion + Na folinic acid 200 mg/m2 on D1, 8, 15, 22 Oxaliplatin 85 mg/m2 on D8, 22 3 weeks rest after D22; Cycle q42d

OFF

FOLFIRI Protocol DRUG

Irinotecan 180 mg /m2 5-FU 400 mg/m2 (bolus) + 2400 mg/m2 as 46 hour infusion Na folinic acid 200 mg/m2 Cycle q2w

FOLFIRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead
• Celgene: collaborator

Study Sites (1)

Praxis für Innere Medizin

Friedrichshafen, Germany

Location

Related Links

• Homepage of the AIO (Arbeitsgemeinschaft Internistische Onkologie in der Deutschen Krebsgesellschaft e.V.)

MeSH Terms

Interventions

IFL protocol

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 6, 2017
• Study Start: January 2, 2018
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

DE (1)