Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Cancer Research and Biostatistics Clinical Trials Consortium
Study ID
NCT01941316
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Irinotecan Sensitive Cancers
  • Non Small Cell Lung Carcinoma
  • Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carfilzomib — DRUG
    20/36 \* mg/m\^2 stepped up dosing, IV infusion (over 30 min), on days 1, 2, 8, 9, 15 and 16 of each 28 day cycle. Number of cycles: 6, or until progression, or unacceptable toxicity, or treatment delay for any reason greater than 3 weeks.
  • Irinotecan — DRUG
    125 mg/m\^2, IV infusion (over 90 min), on days 1, 8, 15 of each 28 day cycle. Number of cycles: 6, or until progression, or unacceptable toxicity, or treatment delay for any reason greater than 3 weeks.

Study Details

The purpose of this study is to determine a well-tolerated dose of Carfilzomib in combination with Irinotecan (Phase 1b portion of the study) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers and to assess the 6 month survival of relapsed small cell lung cancer patients treated with this combination therapy. \*\*The Phase 1b portion of the study is now complete\*\*. Phase 2 portion of the study. The safest, maximally tolerated dose established as established in Phase 1 for Phase 2 is as follows -- Carfilzomib will be provided at 20/36 mg/m\^2 with Irinotecan dosed at 125 mg/m\^2. The purpose of the Phase 2 portion of the study is to assess 6 month survival of relapsed small cell lung cancer ins subjects treated with this combination therapy.

Key Dates

Start date
Nov 30, 2013
Status verified
Apr 2024
Primary completion
Dec 31, 2018
Completion
Jul 1, 2019

Study Design

Enrollment
78 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase II
    Phase II: Stratified, single arm trial using a starting dose of 20/36 mg/m\^2 of carfilzomib and 125 mg/m\^2 of irinotecan, in small cell lung cancer patients who have relapsed on a prior platinum regimen. Stratification for phase II component: 1. Platinum sensitive disease: initial response to platinum-based chemotherapy with progression \> 90 days after last treatment. 2. Platinum refractory disease: No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects that progressed during or within one month of completion of platinum-based chemotherapy will be excluded.
  • Experimental: Phase Ib Cohort 1: 20/27 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
    Cohort 1 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Cohort 1 used a starting dose of 20/27 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
  • Experimental: Phase Ib Cohort 2: 20/36 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
    Cohort 2 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Cohort 2 used a starting dose of 20/36 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
  • Experimental: Phase Ib Cohort 1: 20/45 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
    Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Cohort 3 used a starting dose of 20/45 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.

Primary Outcome Measure

Phase Ib: Maximum Tolerated Dose [ Time Frame: 28 Days ]

Locations (8)

FacilityCityStateZIPSite coordinators
Cancer Treatment Centers of America, Western Regional Medical CenterGoodyearArizona85338-
University of Kentucky Markey Cancer CenterLexingtonKentucky40536-
Norton Cancer InstituteLouisvilleKentucky40202-
Washington University School of MedicineSt LouisMissouri63110-
Providence Portland Medical Center | Earle A. Chiles Research InstitutePortlandOregon97213-
University of Texas Medical Branch at GalvestonGalvestonTexas77555-
Virginia Mason Cancer InstituteSeattleWashington98111-
Aurora Research Institute | Aurora Cancer CareWauwatosaWisconsin53226-

Find similar trials in Goodyear, AZ

By research site
Cancer Treatment Centers of America, Western Regional Medical Center· Goodyear, AZUniversity of Kentucky Markey Cancer Center· Lexington, KYNorton Cancer Institute· Louisville, KYWashington University School of Medicine· St Louis, MOProvidence Portland Medical Center | Earle A. Chiles Research Institute· Portland, ORUniversity of Texas Medical Branch at Galveston· Galveston, TX

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