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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03331640
Recruitment Status : Terminated (slow recruitment)
First Posted : November 6, 2017
Last Update Posted : January 11, 2022
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Ductal Adenocarcinoma Drug: OFF Drug: FOLFIRI Protocol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Health Service Research Study to Investigate Survival of Metastatic Pancreatic Cancer Patients After Sequential Chemotherapy: An AIO Phase II Cross Over Trial (PANTHEON)
Actual Study Start Date : January 2, 2018
Actual Primary Completion Date : September 13, 2021
Actual Study Completion Date : September 13, 2021

Arm Intervention/treatment
Experimental: 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

Experimental: FOLFIRI 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

Primary Outcome Measures :
  1. Progression-free survival during 2nd line therapy (PFS2) [ Time Frame: 49 months ]
    Progression-free survival time from randomization till progress during second line therapy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03331640

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Praxis für Innere Medizin
Friedrichshafen, Germany
Sponsors and Collaborators
Additional Information:
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Responsible Party: AIO-Studien-gGmbH Identifier: NCT03331640    
Other Study ID Numbers: AIO-PAK-0116
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No