RWF_CTC 11-001

Phase 1b/II Trial of Carfilzomib with Irinotecan in Irinotecan-Sensitive Malignancies (Phase Ib) and Small Cell Lung Cancer Patients (Phase II) Who Have Progressed on Prior Platinum-based Chemotherapy (Onyx IST Reference Number: CAR-IST-553)

The purpose of this study is to determine a well-tolerated dose of Carfilzomib in combination with Irinotecan 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.

Inclusion Criteria:

• Patients must have histologically or cytologically-confirmed diagnosis of progressive or recurrent malignancy

• Patients with known brain metastases are eligible only if he/she has been treated for brain metastasis, are asymptomatic after treatment, have a stable CT or MRI of the brain within 28 days of enrollment and are not receiving corticosteroid therapy to control symptoms from brain metastasis. Only a non-enzyme inducing anticonvulsant (e.g., Keppra) will be permitted for those patients requiring anticonvulsants. (Topical and/or inhaled steroids are allowed.)

Exclusion Criteria:

• No prior irinotecan or carfilzomib

• Must not have leptomeningeal metastases.

• Must be no anticipated need for concurrent radiation therapy during protocol treatment.
Phase I/II
Rachel Sanborn, M.D.
Cancer Research And Biostatistics Clinical Trials Consortium (CRAB)
Brenda Fisher
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Westside