Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer (NCT02010567) | Clinical Trial Compass
TerminatedPhase 1/2
Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer
Stopped: The study was halted prematurely at the funding partner's request.
United States32 participantsStarted 2013-12
Plain-language summary
This trial will enroll patients with locally advanced rectal cancer (resectable and non-resectable).The phase Ib dose escalation portion of trial is designed to determine the maximum tolerated dose (MTD) of CRLX101 when combined with standard neoadjuvant therapies capecitabine (Cape) and radiation therapy (XRT). CRLX101 is a nanopharmaceutical (NP) formulation of camptothecin. These results will determine the recommended phase II dose (RP2D) for CRLX101 in this setting. The phase II portion of the trial is designed to evaluate the efficacy and safety of CRLX101 at the RP2D, when combined with capecitabine and radiation therapy prior to surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
✓. Phase Ib and II: surgical candidates, with moderate to high-risk pathologically-confirmed rectal cancer (Tumor (T) and Nodal (N) stage cT3-4N0 or cT1-4N+); clinical staging by endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) is permitted.
✓. Age ≥18 years old
✓. Women of childbearing potential (WOCBP) must have negative pregnancy test within 7 days prior to D1 of treatment
✓. Recommendation to undergo concurrent chemoradiation, as determined by the treating physician
✓. Ability to swallow oral medications
✓. As determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study
✓. Informed consent reviewed and signed
Exclusion criteria
✕. Grade 2 or higher diarrhea at baseline unless deemed by the investigator to be caused by laxatives prescribed for symptomatic partial obstruction (e.g. MiraLAX®)
What they're measuring
1
Maximum Tolerated Dose (MTD) of CRLX101 When Added to Standard Neoadjuvant Chemoradiotherapy Consisting of Capecitabine + Radiotherapy in Locally Advanced Rectal Cancer
✕. Not deemed a candidate for concurrent chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
✕. Specific laboratory exclusion values, including:
✕. Known dihydropyrimidine dehydrogenase (DPD) deficiency
✕. History of Gilbert's syndrome
✕. Those who require therapeutic anticoagulation with coumarin-derivative anticoagulants
✕. Unable to provide informed consent
✕. Receiving any other concurrent cytotoxic, biologic agent(s) or investigational agent