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Clinical Trial 19836

Cancer Type: Thoracic
Interventions:Paraplatin (carboplatin); RRx-001; carboplatin; cisplatin; etoposide

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Alberto Chiappori

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

REPLATINUM: A Phase 3, Controlled, Open-label,Randomized Study of RRx-001 Administered Sequentially with a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond Small Cell Carcinoma

Summary

Objective

Primary Objective: To compare the Progression Free Survival (PFS) defined as the time from randomization until disease progression or death between the two arms. Secondary Objectives: To compare ORR (overall response rate, RECIST 1.1) between the two arms. To compare overall survival (OS), defined as the time from randomization to death from any cause between switched-over and non-switched-over patients. Tertiary Objectives: To compare the disease control rate (DCR) defined as the sum of complete responses(CR) + partial responses (PR) + stable disease (SD). To correlate change in circulating tumor cells with response. To compare the Time Without Symptoms and Grade 3-4 Hematologic Toxicity (TWiST)and Quality-Adjusted TWiST (Q-TWiST). To compare platinum sensitization rates between the 2 arms. To compare the percentage of treatment delays and dose reductions. The proportion of patients on the RRx-001 arm that developed pseudoprogression. Exploratory Objectives: To correlate density of TGF-beta 1 receptor in tumor with response. To correlate CD-47 expression on circulating tumor cells (CTCs) with response. To correlate SIRP-alpha expression on circulating monocytes with response. To correlate density of tumor associated macrophages with response. To estimate the proportion of patients on the RRx-001 arm that were treated beyond RECIST 1.1 -defined progressive disease. To compare between the two treatment arms the median time to onset of severe myelosuppression, a composite event comprising Grade 3-4 thrombocytopenia, leukopenia and neutropenia. To compare the hematologic toxicity profile of each arm, which includes percent a. Grade 4 neutropenia b. > Grade 3 anemia c. Grade 4 thrombocytopenia d. Febrile neutropenia e. Platelet transfusions. Safety Objective: To evaluate the safety and tolerability assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs,and weight.

Inclusion Criteria

  • Age ≥ 18 and >Prior platinum treatment is required
  • Biopsy confirmation of small cell carcinoma from any primary
  • Capable of providing informed consent and complying with trial procedures
  • Measurable disease by RECIST 1.1. Measurable lesions will be confirmed by imaging (CT scan)
  • PS 0-1

  • Exclusion Criteria

  • Symptomatic central nervous system metastases or neurologically unstable patients that are on increasing steroid dose.
  • Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, certain heart conditions, or mental illness/social situations that would limit compliance with study requirements.
  • History of an allergic reaction to previously received platinum-based regimen, or history of having to discontinue previously received platinum-based regimen secondary to toxicity
  • Any clinical laboratory findings, which give reasonable suspicion of a disease or condition that contraindicates the use of any study medication or renders the patient at high risk from treatment
  • Uncontrolled or symptomatic pleural or pericardial effusion
  • Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants