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American Family Children's Hospital

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Protocol No. NCI9837

Principal Investigator Leal, Ticiana

Phase I/II

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title Phase I Study of TRC102 in Combination with Cisplatin and Pemetrexed in Patients with Advanced Solid Tumors, with Expansion Cohort in Mesothelioma / Phase II Study of TRC102 with Pemetrexed in Patients Refractory to Pemetrexed and Cisplatin or Carboplatin

Objective The purpose of this study is to test any good or bad side effects of the study drug called TRC102 in combination with pemetrexed in patients with malignant mesothelioma who received first line standard therapy with pemetrexed and cisplatin or carboplatin and their cancer has grown within 3 months of completion. Researchers hope to learn if the study drug TRC102 in combination with pemetrexed can reverse resistance to pemetrexed. This drug has been tested alone and in combination with pemetrexed. This study will test different doses of the TRC102 to see which dose is safer and find out what effects it has on solid tumors in combination with pemetrexed and cisplatin. Once the safe dose of the combination is established, it will be tested in patients with untreated inoperable malignant mesothelioma to see if the treatment will shrink tumors or for how long the tumor will be stable.

TRC102 is an experimental drug, this means that TRC102 has not been approved by the US Food and Drug Administration (FDA) for the treatment of your type of cancer and can only be given in a research study. TRC102 will be taken orally on Days 1-4 of each cycle. Cisplatin and pemetrexed will be given intravenously (through your vein) over 40-70 minutes on Day 1 of each cycle

Description All study participants will get the same study drugs

Pemetrexed will be given in combination with TRC102 on the first day of each cycle for 6 cycles. A treatment cycle is 3 weeks

You will receive the TRC102 and pemetrexed for up to 6 cycles or 18 weeks

After you finish TRC102 and pemetrexed, your doctor will continue to watch you for side effects and follow your condition for eight (8) weeks

Key Eligibility
  • Arm A Dose Escalation: Patients with histologically or cytologically proven advanced solid tumors for which standard treatments are not available; < 2 prior cytotoxic chemotherapy regimen
  • Arm A Dose Level 4: Patients with histologically proven chemotherapy-naïve advanced unresectable solid tumors for which pemetrexed combined with cisplatin is an indicated regimen
  • Arm A 14-patients expansion cohort: Patients with histologically or cytologically proven chemotherapy naïve unresectable malignant pleural or peritoneal mesothelioma
  • Arm B: Patients with malignant pleural or peritoneal mesothelioma who had progressed while being treated with or had recurred within 6 months of being treated with pemetrexed and cisplatin or carboplatin frontline. Intervening treatment is allowed
  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study are not eligible
  • Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial
  • Pregnant women are excluded from this study
  • HIV-positive patients on combination antiretroviral therapy are ineligible.
  • Patients with thromboembolic disease and on anticoagulation are not eligible
  • Patients with known disorders associated with hemolysis are not eligible

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics