RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
- Conditions
- Carcinoma, Non-Small-Cell LungNeuroendocrine TumorsSmall Cell CarcinomaOvarian Epithelial Cancer
- Interventions
- Registration Number
- NCT02489903
- Lead Sponsor
- EpicentRx, Inc.
- Brief Summary
This study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize patients who previously received and now have failed a platinum based doublet regimen. RRx-001 is administered with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy.
- Detailed Description
This is an open label, four 'cohort' study for administration of RRx-001 with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy according to the treatment schedule listed below. Small cell carcinoma and ovarian cohort participants will be randomized to 1 of 2 treatment arms, respectively. Neuroendocrine and NSCLC patients will be enrolled to single arms.
Participants with SCC will receive one of the following; RRx-001 followed by platinum doublet chemotherapy or platinum based chemotherapy alone. HGNEC, RRx-001 followed by platinum doublet chemotherapy. NSCLC, RRx-001 followed by platinum doublet chemotherapy. Participants with Platinum Refractory/Resistant Ovarian and MMMT will receive one of the following, RRx-001 followed by platinum doublet chemotherapy or chemotherapy alone.
Approximately 213 participants will be enrolled.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Small Cell Lung Cancer (Arm 2) Cisplatin Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity Non Small Cell Lung Cancer Paclitaxel RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum). Non Small Cell Lung Cancer Nab-Paclitaxel RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum). Small Cell Lung Cancer (Arm 2) Carboplatin Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity Ovarian epithelial cancer (Arm 2) Taxane Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity Ovarian epithelial cancer (Arm 2) Doxil Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity Small Cell Lung Cancer (Arm 1) RRx-001 RRx-001 weekly for 3 weeks followed by up to 4 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 and carboplatin or cisplatin (for patients with stable disease (SD) or better at discontinuation of platinum). Small Cell Lung Cancer (Arm 1) Cisplatin RRx-001 weekly for 3 weeks followed by up to 4 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 and carboplatin or cisplatin (for patients with stable disease (SD) or better at discontinuation of platinum). Small Cell Lung Cancer (Arm 1) Etoposide RRx-001 weekly for 3 weeks followed by up to 4 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 and carboplatin or cisplatin (for patients with stable disease (SD) or better at discontinuation of platinum). Small Cell Lung Cancer (Arm 2) Etoposide Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity Small Cell Lung Cancer (Arm 1) Carboplatin RRx-001 weekly for 3 weeks followed by up to 4 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 and carboplatin or cisplatin (for patients with stable disease (SD) or better at discontinuation of platinum). Small Cell Lung Cancer (Arm 2) Irinotecan Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity Small Cell Lung Cancer (Arm 2) Vinorelbine Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity Non Small Cell Lung Cancer Cisplatin RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum). Non Small Cell Lung Cancer Carboplatin RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum). Non Small Cell Lung Cancer Pemetrexed RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum). Neuroendocrine tumors Cisplatin RRx-001 weekly until progression followed by up to 6 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum). Neuroendocrine tumors Etoposide RRx-001 weekly until progression followed by up to 6 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum). Ovarian epithelial cancer (Arm 2) Carboplatin Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity Neuroendocrine tumors Carboplatin RRx-001 weekly until progression followed by up to 6 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum). Ovarian epithelial cancer (Arm 2) Etoposide Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity Ovarian epithelial cancer (Arm 1) Carboplatin RRx-001 weekly for 2 weeks followed by 2 cycles of Carboplatin chemotherapy and then RRx-001/Carboplatin maintenance (for patients with stable disease or better at discontinuation of platinum). Ovarian epithelial cancer (Arm 2) Vinorelbine Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity Ovarian epithelial cancer (Arm 2) Gemcitabine Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity Non Small Cell Lung Cancer RRx-001 RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum). Neuroendocrine tumors RRx-001 RRx-001 weekly until progression followed by up to 6 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum). Ovarian epithelial cancer (Arm 1) RRx-001 RRx-001 weekly for 2 weeks followed by 2 cycles of Carboplatin chemotherapy and then RRx-001/Carboplatin maintenance (for patients with stable disease or better at discontinuation of platinum).
- Primary Outcome Measures
Name Time Method Overall Survival From start of treatment through death for up to 64 months from Start of Treatment. From the time from enrollment until the time of death from any cause or last follow-up. Patients will be followed clinically as outlined in the treatment schedule and will be followed off study for death.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Assessed up to 49 months Overall Response Rate (ORR) will be defined as the proportion of patients with a CR or a PR per RECIST v1.1 based upon the best response as assessed; confirmation of response was not required, assessed up to 49 months.
Disease Control Rate (DCR) Assessed up to 49 months The percentage of patients who have achieved complete response, partial response and stable disease (as per RECIST v1.1), assessed up to 49 months.
Progression Free Survival (PFS) Assessed up to 49 months Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 49 months.
Trial Locations
- Locations (10)
Stanford University
🇺🇸Palo Alto, California, United States
Baptist Health
🇺🇸Lexington, Kentucky, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Henry Ford Allegiance Health
🇺🇸Jackson, Michigan, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
University of Cincinnati Cancer Institute
🇺🇸Cincinnati, Ohio, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
VA Connecticut Cancer Center
🇺🇸West Haven, Connecticut, United States