Trial Outcomes & Findings for Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer (NCT NCT04406857)
NCT ID: NCT04406857
Last Updated: 2025-02-26
Results Overview
The maximum-tolerated dose is defined as the dose below which 2 or more of 6 patients experience dose-limiting toxicities attributable to ropidoxuridine.
TERMINATED
PHASE1
1 participants
Up to 38 days
2025-02-26
Participant Flow
Participant milestones
| Measure |
Treatment (Ropidoxuridine, Capecitabine, Radiation Therapy)
Patients receive ropidoxuridine PO QD over 7 days per week and capecitabine PO BID over 6 days per week for 6 weeks. Patients also undergo radiation therapy over 1 fraction per day for 5 days per week (Monday-Friday) during weeks 1-5 and for 3 days during week 6 in the absence of disease progression or unacceptable toxicity. Approximately 8-12 weeks after completion of treatment with ropidoxuridine, capecitabine, and radiation therapy, patients undergo standard of care surgery.
Capecitabine: Given PO
Radiation Therapy: Undergo radiation therapy
Ropidoxuridine: Given PO
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|---|---|
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Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Ropidoxuridine, Capecitabine, Radiation Therapy)
n=1 Participants
Patients receive ropidoxuridine PO QD over 7 days per week and capecitabine PO BID over 6 days per week for 6 weeks. Patients also undergo radiation therapy over 1 fraction per day for 5 days per week (Monday-Friday) during weeks 1-5 and for 3 days during week 6 in the absence of disease progression or unacceptable toxicity. Approximately 8-12 weeks after completion of treatment with ropidoxuridine, capecitabine, and radiation therapy, patients undergo standard of care surgery.
Capecitabine: Given PO
Radiation Therapy: Undergo radiation therapy
Ropidoxuridine: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 38 daysPopulation: Data not collect and analyzed
The maximum-tolerated dose is defined as the dose below which 2 or more of 6 patients experience dose-limiting toxicities attributable to ropidoxuridine.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 38 daysPopulation: Data not collect and analyzed
Assessed by Common Terminology Criteria for Adverse Events version 5 and reached when any two grade 3 treatment-related non-hematologic toxicities or one grade 4 treatment-related hematologic and/or gastrointestinal toxicity are observed in two of the 6 patients enrolled at that dose level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 8-12 weeks following completion of chemotherapyPopulation: Data not collect and analyzed
Will be measured on continuous and binary scales will be assessed using Wilcoxon signed rank or McNemar's tests, respectively (two-sided; alpha = 0.05). Associations between therapeutic response and baseline biomarker values or temporal changes in biomarkers will be explored using Fisher's exact tests or Wilcoxon rank sum tests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to ropidoxuridine dose and at 30, 60, 120, and 240 minutes after ropidoxuridine dose on day 8, then at 1-2 hours after ropidoxuridine dose on days 21 and 35Population: Data not collect and analyzed
Will correlate these levels with ropidoxuridine plasma pharmacokinetics. Two-sided Fisher's z-test with significance level of 0.05 and power of 80% will be used and the study will reject the null hypothesis (lack of correlation or r0 = 0) if we observe a correlation with r ranging from 0.79 for N = 10 subjects to 0.49 for N = 30 subjects.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to the ropidoxuridine on day 8, and at 1-2 hours following the ropidoxuridine dose on days 21 and 35Population: Data not collect and analyzed
For the correlation of percentage of ropidoxuridine deoxyribonucleic acid incorporation in circulating granulocytes and peripheral blood counts and toxicities, assuming the target prevalence of grade 3/4 toxicity of 30%, the study will have a power of 80% with significance level of 0.05 on a two-sample means test to rule out the null hypothesis (equal means in groups with/ without grade 3/4 toxicity, m0 = m1) if the observed mean percentage of ropidoxuridine-deoxyribonucleic acid incorporation for patients with grade 3/4 toxicity is m1 = 3.3 times the mean m0 in the other group for N = 10 enrolled subjects, and m1 = 2.1 times the mean m0 for N = 30.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the time of surgeryPopulation: Data not collect and analyzed
In rectal cancer, the absence of viable tumor cells in the resection specimen (primary tumor mass, surrounding tissue and lymph nodes, T0 N0 M0) at the time of surgery, termed pathologic complete response. Pathologic complete response determination will be made by the pathologist at the treating institution.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6-10 weeks following completion of therapyPopulation: Data not collect and analyzed
Neoadjuvant rectal score is calculated based on the clinical T stage (cT), pathological T (pT) and pN stages as neoadjuvant rectal score = \[5pN- 3 (cT- pT) + 12\]2 / 9.61.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPopulation: Data not collect and analyzed
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPopulation: Data not collect and analyzed
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Ropidoxuridine, Capecitabine, Radiation Therapy)
Serious adverse events
| Measure |
Treatment (Ropidoxuridine, Capecitabine, Radiation Therapy)
n=1 participants at risk
Patients receive ropidoxuridine PO QD over 7 days per week and capecitabine PO BID over 6 days per week for 6 weeks. Patients also undergo radiation therapy over 1 fraction per day for 5 days per week (Monday-Friday) during weeks 1-5 and for 3 days during week 6 in the absence of disease progression or unacceptable toxicity. Approximately 8-12 weeks after completion of treatment with ropidoxuridine, capecitabine, and radiation therapy, patients undergo standard of care surgery.
Capecitabine: Given PO
Radiation Therapy: Undergo radiation therapy
Ropidoxuridine: Given PO
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|---|---|
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Gastrointestinal disorders
Cecal inflammation
|
100.0%
1/1 • Number of events 1 • Adverse events were collected and graded from baseline until completion of the study up to 1 year.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60