Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer

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Brief Title

Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer

Official Title

A Randomized Multi-center Phase I/II Trial of ICM (Irinotecan, Cisplatin, Mitomycin C) With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer

Brief Summary

      Patients whose pancreatic cancers have defects in the BRCA/Fanconi DNA repair pathway or
      other defects in homologous repair will have cancers that respond to olaparib when given in
      combination with the DNA damaging agents, irinotecan, cisplatin, mitomycin C (ICM).
    

Detailed Description

      The trial is designed to evaluate the role of Parp inhibitor based therapy, combining the
      most well studied and potent Parp inhibitor currently available with a low-dose combination
      of DNA damaging agents to optimize the effects of Parp inhibition. To ensure optimal response
      rates in the trial, to enrich our population for patients likely to achieve the best clinical
      response to Parp inhibitor based therapy, we will recruit and enroll patients with known BRCA
      mutations, patients of Jewish ancestry, patients with familial pancreatic cancer, as well as
      with sporadic pancreatic cancer. We will test patients and their cancers for other inherited
      or acquired defects in homologous DNA repair. For the phase 1 study, we will enroll up to 30
      patients. For the phase 2 component of the study, 100 patients with locally, advanced,
      unresectable or metastatic pancreatic cancer will be enrolled. An initial phase I analysis
      will be performed to test the safety of the ICM with Olaparib regimen at the doses we predict
      will be effective for the phase 2 and ensure that these doses are below the maximum tolerated
      dose. For this phase 1 we will use a standard 3+3 design and will test the following dose
      regimens in a 28 day cycle:

      Dose level 1: Cisplatin/Irinotecan i.v.(day 1, 8) and Olaparib (100 mg bid p.o., Day 1 & Day
      8) Dose level 2: Cisplatin/Irinotecan i.v.(day 1, 8) and Olaparib 100 bid p.o. day 1-3, day
      8-10 (if this dose is not tolerated, go to Dose 5: Mitomycin + Olaparib Dose level 1) Dose
      level 3: Cisplatin/Irinotecan i.v.(day 1, 8) and Olaparib 200 bid p.o.day 1-3, day 8-10 (if
      this dose is not tolerated, go to Dose 5: Mitomycin + Olaparib Dose level 2) Dose level 4:
      Cisplatin/Irinotecan i.v.(day 1, 8) and Olaparib 200 bid p.o. day 1-12 (if this dose is not
      tolerated, go to Dose 5: Mitomycin + Olaparib Dose level 3)) Dose level 5:
      Cisplatin/Irinotecan i.v.(day 1, 8), Mitomycin Day 1 (5 mg/m2 IV), along with the established
      tolerated dose level of Olaparib.

      Other intermediate dose schedules of Olaparib may be considered to achieve the most optimal
      tolerable regimen" If there are DLTs at Dose 1, we will reduce the duration of Olaparib

      Note: The Principal Investigator and Astrazeneca decided not to move forward with the Phase
      II part of the study. Therefore the arms of Irinotecan, Cisplatin, Mitomycin C with Olaparib
      versus Irinotecan, Cisplatin, Mitomycin C without Olaparib will not be compared.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of Participants Who Experienced a Dose Limiting Toxicity to Determine the Maximum Tolerated Dose (MTD)

Secondary Outcome

 Number of Years From Cycle 1, Day 1 On-Study to Date of Death

Condition

Pancreatic Cancer

Intervention

Irinotecan

Study Arms / Comparison Groups

 Irinotecan, Cisplatin, Olaparib, then add Mitomycin-C
Description:  A 3+3 dose escalation design will be used starting with dose 1. The maximally tolerated dose is defined as the highest dose for which at most 1 out of 6 patients experiences a DLT. We will use 3 patients per dose cohort. If 0 of 3 patients have a DLT (see section 5a) then the escalation will be continued at the next dose level. If 1 of 3 patients have a DLT then three more patients will be enrolled at this dose. If 1 of 6 patients has a DLT then the dose escalation will continue. If 2 or more of the first 3 patients, or >2 of 6 patients treated have a DLT at the dose level, we will reduce the dose to the previous dose level of Olaparib for the phase 2 and then test Mitomycin C (phase 1 dose 5). If DLTs are observed at our dose 1 regimen, we will reduce the duration of Olaparib from day 1 and day 8 to just day 1 (dose level -1) and we will not test Mitomycin C in the trial.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

18

Start Date

January 2011

Completion Date

February 2016

Primary Completion Date

January 2014

Eligibility Criteria

        Inclusion Criteria:

          1. Provision of fully informed consent prior to any study specific procedures.

          2. Histologic or cytologic confirmation of exocrine pancreatic adenocarcinoma.

          3. Locally advanced, inoperable (due to venous or arterial encasement ≥ 180° of the
             vessel), and/or metastatic disease by imaging (CT, MRI, or EUS). Acquisition of tissue
             rather than cytology is encouraged if the patient gives informed consent.

          4. Measurable disease according to RECIST 1.1 criteria

          5. Prior neoadjuvant or adjuvant therapy is acceptable, as long as no more than one drug
             of the ICM regimen was used.

          6. No prior chemotherapy for advanced pancreatic cancer with Olaparib is permitted.
             Gemzar, Tarceva, and 5-FU or Xeloda, Oxaliplatin Taxotere, and FOLFIRINOX are
             permitted.

          7. Three weeks since last surgery or chemotherapy mentioned in #5 above or
             investigational therapies. Four weeks since radiation.

          8. No prior PARP inhibitors of any type

          9. ECOG status < 3

         10. Life expectancy > 3 months

         11. Patients must have normal organ and bone marrow function

         12. Age >=18.

         13. Patient is willing and able to comply with the protocol for the duration of the study
             including treatment, scheduled visits, and examinations.

         14. Evidence of non-childbearing status for women of childbearing potential, or
             postmenopausal status: negative urine or serum pregnancy test within 28 days of study
             treatment, confirmed prior to treatment on day 1

             For inclusion in genetic research, patients must fulfill the following criterion:

         15. Provision of informed consent for genetic research. If a patient declines to
             participate in the genetic research, there will be no penalty or loss of benefit to
             the patient. The patient will not be excluded from other aspects of the study.

        Exclusion Criteria:

          1. Patients with second primary cancer, except: adequately treated non-melanoma skin
             cancer or curatively treated in-situ solid tumors with no evidence of disease for ≥ 5
             years.

          2. Patients receiving any systemic chemotherapy, radiotherapy (except for palliative
             reasons), less than 3 weeks from the last dose prior to study treatment (or a longer
             period depending on the defined characteristics of the agents used). The patient can
             receive a stable dose of bisphosphonates for bone metastases before and during the
             study as long as these were started at least 4 weeks prior to treatment.

          3. For patients who have locally advanced pancreatic cancer only, if they have received
             therapeutic doses of radiation therapy to their pancreatic bed (~50 Gy) for treatment
             of their locally advanced pancreatic cancer

          4. Patients having already had prior chemotherapy for more than 12 months for their
             advanced pancreatic cancer (not including adjuvant/neoadjuvant)

          5. Patients receiving the following classes of inhibitors of CYP3A4 (see Section for
             guidelines and wash out periods).

          6. Current use of azole antifungals, macrolide antibiotics, or protease inhibitors

          7. Unresolved toxicities (>CTCAE 4.0 grade 2) caused by previous cancer therapy.

          8. Patients with known brain metastases. A scan to confirm the absence of brain
             metastases is not required unless the initial examination reveals CNS signs of
             disease.

          9. Major surgery less than 3 weeks prior to starting study treatment and patients must
             have recovered from any effects of any major surgery.

         10. Patients considered a poor medical risk due to serious, uncontrolled medical
             disorders, non-malignant systemic disease, or active, uncontrolled infection. Examples
             include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3
             months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal
             cord compression, superior vena cava syndrome, or any psychiatric disorder that
             prohibits obtaining informed consent.

         11. Patients unable to swallow oral medication and patients with gastrointestinal
             disorders likely to interfere with absorption of the study medication.

         12. Breast feeding and/or pregnant women.

         13. Immunocompromised patients, e.g., patients who are known to be serologically positive
             for human immunodeficiency virus (HIV).

         14. Patients with known active hepatic disease (i.e., Hepatitis B or C). Patients with a
             known hypersensitivity to Olaparib or any of the excipients of the product or history
             of severe allergic reactions to platinums or chemotherapy.

         15. Grade 2 neuropathy at entry from any etiology, including diabetes (in view of
             Cisplatin).

         16. Prior episodes of recurrent deep vein thrombosis or Trousseau's Syndrome unless the
             patient is successfully anticoagulated. If a patient has had a history of clotting or
             is suspected to have Trousseau's syndrome and is not anticoagulated, a D-Dimer level
             will be checked. If it is > 3 x ULN, patients will be expected to be anticoagulated
             with low molecular weight heparinoids (i.e. Lovonox).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Goggins, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01296763

Organization ID

J1070

Secondary IDs

RC2CA148346-01

Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Michael Goggins, MD, Principal Investigator, Sol Goldman Pancreatic Cancer Research Center, JHMI


Verification Date

February 2016