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

Conditions

• Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Irinotecan — DRUG
  Irinotecan 70 mg/m2 IV, Days 1 and 8
• Cisplatin — DRUG
  Cisplatin 25 mg/m2 IV, Days 1 and 8
• Olaparib (for levels 1 and 5) — DRUG
  Olaparib 100 mg bid oral, Days 1 and 8
• Olaparib (for dose level 2) — DRUG
  Olaparib 100mg bid oral, Day 1-3, Day 8-10
• Mitomycin-C — DRUG
  Mitomycin 5 mg/m2 IV, Day 1

Study Details

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).

Key Dates

Start date

Jan 31, 2011

Status verified

Feb 2016

Primary completion

Jan 31, 2014

Completion

Feb 29, 2016

Study Design

Enrollment

18 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Irinotecan, Cisplatin, Olaparib, then add Mitomycin-C
  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.

Primary Outcome Measure

Number of Participants Who Experienced a Dose Limiting Toxicity to Determine the Maximum Tolerated Dose (MTD) [ Time Frame: 2 years ]

Locations (2)

Find similar trials in Baltimore, MD

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