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

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ClinicalTrials.gov Identifier: NCT03331640
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Celgene International II SARL
Information provided by (Responsible Party):
AIO-Studien-gGmbH

Tracking Information
First Submitted Date  ICMJE November 1, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE January 2, 2018
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
Progression-free survival during 2nd line therapy (PFS2) [ Time Frame: 49 months ]
Progression-free survival time from randomization till progress during second line therapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03331640 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Health Service Research Study to Investigate Survival of Metastatic Pancreatic Cancer Patients After Sequential Chemotherapy
Official Title  ICMJE A Health Service Research Study to Investigate Survival of Metastatic Pancreatic Cancer Patients After Sequential Chemotherapy: An AIO Phase II Cross Over Trial (PANTHEON)
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 arms. Cross-over will take place after progress during second line therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Ductal Adenocarcinoma
Intervention  ICMJE
  • Drug: OFF

    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

  • Drug: FOLFIRI Protocol
    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
Study Arms  ICMJE
  • Experimental: OFF
    Intervention: Drug: OFF
  • Experimental: FOLFIRI
    Intervention: Drug: FOLFIRI Protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2017)
204
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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
  2. Age ≥ 18 years at time of study entry
  3. Unresectable adenocarcinoma of the pancreas previously treated in the palliative setting with gemcitabine and nabpaclitaxel (Abraxane®)
  4. Adequately documented recurrence and disease status after/under 1st line (Best response, duration of treatment, time to progression, preexisting PNP and other side effects)
  5. Radiologically confirmed disease progression during 1st-line therapy and measurable reference cancer site(s) as defined by RECIST1.1
  6. Randomization and start of 2nd-line treatment possible within 4 weeks after radiologically documented disease progression during 1st-line therapy
  7. ECOG performance status 0-2
  8. No prior radiotherapy
  9. 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
  10. 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
  11. 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 Criteria:

  1. Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 3 months prior to study start)
  2. Preexisting polyneuropathy (PNP) ≥ grade 3 [National Cancer Institute Common Toxicity Criteria grade 3 or 4 sensory or motor neuropathy]
  3. Prior or concurrent malignancy (other than pancreatic cancer) which either progresses or requires active treatment. Exceptions are: basal cell cancer of the skin
  4. History of DPD deficiency
  5. Morbus Gilbert
  6. History of hypersensitivity to any of the study drugs or any of the constituents of the products
  7. Medication that is known to interfere with any of the agents applied in the trial
  8. 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)
  9. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
  10. Any medical condition that contraindicates dosing with any of the IMPs or constitutes a safety risk for the patient including but not limited to:

    1. chronic inflammatory bowel disease and/or bowel obstruction.
    2. active uncontrolled infection
    3. clinically significant bleeding or bleeding diathesis
    4. clinically significant stomatitis
    5. active ulceration of the gastrointestinal tract
  11. Previous enrollment or randomization in the present study (does not include screening failure)
  12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG
  13. 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]
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aysun Karatas, Dr. 0308145344 ext 31 info@aio-studien-ggmbh.de
Contact: Helmut Oettle, Prof. Dr.
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03331640
Other Study ID Numbers  ICMJE AIO-PAK-0116
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AIO-Studien-gGmbH
Study Sponsor  ICMJE AIO-Studien-gGmbH
Collaborators  ICMJE Celgene International II SARL
Investigators  ICMJE Not Provided
PRS Account AIO-Studien-gGmbH
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP