Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT02935309|
Recruitment Status : Active, not recruiting
First Posted : October 17, 2016
Last Update Posted : March 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer Rectal Adenocarcinoma||Drug: Lenvatinib Drug: Capecitabine Radiation: External Radiation Therapy (XRT)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Pre-operative Capecitabine and Lenvatinib With External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma|
|Actual Study Start Date :||October 14, 2016|
|Actual Primary Completion Date :||October 11, 2019|
|Estimated Study Completion Date :||November 2021|
Experimental: Pre-Surgery Chemotherapy/Radiotherapy
Pre-surgery chemotherapy and external radiation therapy. Dose escalation of Lenvatinib; fixed dose Capecitabine; Radiotherapy. Lenvatinib and capecitabine will be started on day 1 with radiation and will be discontinued on the last day of radiation. Surgical resection should occur between 6 - 10 weeks after the participant completes preoperative lenvatinib, capecitabine, and radiation therapy. Postoperative chemotherapy after surgery will be given at investigator's discretion.
Pre-surgery Lenvatinib, days 1 - 5. Dose Escalation Levels: 1.) 10 mg by mouth (PO) daily (QD); 2.) 14 mg PO QD; 3.) 20 mg PO QD; 4.) 24 PO QD.
Other Name: E7080
Pre-surgery Capecitabine, 850 mg/m^2, twice a day (BID) on days 1-5 for 5½ -6 weeks.
Radiation: External Radiation Therapy (XRT)
Pre-surgery RT: Participants will receive 6 weeks of radiation therapy. The radiation sessions will be daily, Monday through Friday, except for holidays.
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 6 months ]MTD of lenvatinib used in combination with capecitabine and external beam radiation as neoadjuvant therapy for patients with locally advanced rectal carcinoma. The MTD of lenvatinib will be defined as the highest dose level at which no more than 1 out of 6 participants experiences dose-limiting toxicity (DLT). DLT: Any of the hematology or non-hematologic toxicities noted in Table 3 of the protocol, considered to be at least possibly related to lenvatinib and/or capecitabine.
- Rate of Pathologic Response [ Time Frame: Up to 36 months ]Pathologic response rate after pre-operative therapy and surgery. Pathologic Complete Response (pCR) will be defined as pathologic proof of a complete response based on histologic evaluation of the resected specimen.
- Occurrence of Treatment Related Adverse Events [ Time Frame: Up to 36 months ]To further define safety profile of the combination. Adverse events will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.
- Rate of Potential Biomarkers for Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Up to 36 months ]Investigators will identify potential biomarkers for VEGF pathway and attempt to correlate with pCR. The associations of the potential biomarkers and radiosensitivity index (RSI) with pCR will be examined using logistic regression. A two-sided p-value of <0.05 will be considered statistically significant.
- Radiosensitivity Index (RSI) [ Time Frame: Up to 36 months ]To determine if low radiosensitivity index (RSI) will correlate with pathologic complete response (pCR). pCR will be examined using logistic regression. A two-sided p-value of <0.05 will be considered statistically significant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935309
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Richard Kim, M.D.||H. Lee Moffitt Cancer Center and Research Institute|