Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is negative for RAS wild-type colorectal cancer has spread to other places in the body (metastatic), and/or cannot be removed by surgery (unresectable), and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab may work better in treating patients with colorectal cancer than with the usual treatment of regorafenib or TAS-102.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To compare the overall survival (OS) in molecularly selected patients with metastatic colorectal cancer (CRC) receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib). SECONDARY OBJECTIVES: I. To compare the progression free survival (PFS) in molecularly selected patients with metastatic CRC receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib). II. To define the objective response rate (ORR) in patients receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib). III. To define the clinical benefit rate (CBR = complete response + partial response + stable disease >= 4 months) in patients receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib). IV. To compare the safety and tolerability of panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib). V. To compare quality of life (QOL) between panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib) as measured by the linear analogue self-assessment (LASA) questionnaires. CORRELATIVE RESEARCH OBJECTIVES: I. To assess plasma pharmacodynamics biomarkers of response and resistance to therapy. II. To explore any correlation between tissue and blood based biomarkers and clinical outcomes. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive panitumumab intravenously (IV) over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive trifluridine and tipiracil hydrochloride orally (PO) twice daily (BID) on days 1-5 and 8-12, or regorafenib PO once daily (QD) on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 3 years after randomization. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Metastatic Colon Adenocarcinoma
  • Metastatic Colorectal Carcinoma
  • Metastatic Rectal Adenocarcinoma
  • Rectal Neoplasms
  • Stage III Colon Cancer AJCC v8
  • Stage III Colorectal Cancer AJCC v8
  • Stage III Rectal Cancer AJCC v8
  • Stage IIIA Colon Cancer AJCC v8
  • Stage IIIA Colorectal Cancer AJCC v8
  • Stage IIIA Rectal Cancer AJCC v8
  • Stage IIIB Colon Cancer AJCC v8
  • Stage IIIB Colorectal Cancer AJCC v8
  • Stage IIIB Rectal Cancer AJCC v8
  • Stage IIIC Colon Cancer AJCC v8
  • Stage IIIC Colorectal Cancer AJCC v8
  • Stage IIIC Rectal Cancer AJCC v8
  • Stage IV Colon Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IV Rectal Cancer AJCC v8
  • Stage IVA Colon Cancer AJCC v8
  • Stage IVA Colorectal Cancer AJCC v8
  • Stage IVA Rectal Cancer AJCC v8
  • Stage IVB Colon Cancer AJCC v8
  • Stage IVB Colorectal Cancer AJCC v8
  • Stage IVB Rectal Cancer AJCC v8
  • Stage IVC Colon Cancer AJCC v8
  • Stage IVC Colorectal Cancer AJCC v8
  • Stage IVC Rectal Cancer AJCC v8
  • Unresectable Colon Adenocarcinoma
  • Unresectable Colorectal Carcinoma
  • Unresectable Rectal Adenocarcinoma

NCT number NCT03992456
Study type Interventional
Source Academic and Community Cancer Research United
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 24, 2020
Completion date October 7, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05691491 - Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness Phase 1/Phase 2
Terminated NCT04832763 - Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer N/A
Active, not recruiting NCT04164069 - Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab Phase 1
Active, not recruiting NCT03981614 - Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer Phase 2
Recruiting NCT05863195 - Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial Phase 3
Active, not recruiting NCT03983993 - Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer Phase 2
Completed NCT04597151 - Diet Education Program for Stage I-IV Colorectal Cancer Survivors N/A
Not yet recruiting NCT05518032 - Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC) Phase 2
Recruiting NCT05803382 - Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers Phase 1
Not yet recruiting NCT05356897 - Tucatinib Combined With Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study Phase 2
Recruiting NCT04314401 - National Cancer Institute "Cancer Moonshot Biobank"
Suspended NCT04111172 - A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma Phase 2
Recruiting NCT05627635 - FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer Phase 1/Phase 2
Active, not recruiting NCT04362839 - Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer Phase 1
Recruiting NCT05672316 - Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy Phase 1/Phase 2
Recruiting NCT05733000 - CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors Phase 2
Active, not recruiting NCT04117945 - Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer Phase 2
Active, not recruiting NCT02983578 - Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer Phase 2
Recruiting NCT04693377 - Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial N/A
Recruiting NCT06265285 - Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program Phase 2