Phase 2
N=42
Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer
Colon Adenocarcinoma · Rectal Adenocarcinoma · Recurrent Colon Carcinoma · Recurrent Rectal Carcinoma · Stage IVA Colon Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02393755 ↗Enrolled (actual)
42
Serious AEs
23.8%
Results posted
Jul 2020
Primary outcome: Primary: To Examine the DLT — 200 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Capecitabine (Drug); Laboratory Biomarker Analysis (Other); Nintedanib (Drug); Pharmacological Study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Examine the DLT |
200 | — |
| PRIMARY Progression Free Survival (PFS) Rate, Defined as the Proportion of Patients Who Survive Without Disease Progression Via the RECIST Version 1.1 (Phase II) |
41.7 | — |
| SECONDARY Median PFS (Phase II) |
3.4 | — |
| SECONDARY Median OS (Phase II) |
8.9 | — |
| SECONDARY Objective Response Rate |
58.3 | — |
| SECONDARY Aggregate Rates of Adverse Events Measured by CTCAE Version 4.0 (Phase II) |
3; 13; 16; 1; 3 | — |
Summary
This phase I/II trial studies the side effects and best dose of nintedanib when given together with capecitabine and to see how well they work in treating patients with colorectal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nintedanib with capecitabine may be a better treatment for colorectal cancer.
Eligibility Criteria
Inclusion Criteria
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Hemoglobin >= 9 g/dL
- Absolute neutrophil count >= 1500/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine = 50 mL/min by Cockcroft-Gault equation
- Males = (140 -age (yrs) (body weight (kg)/(72) (serum creatinine) (mg/dL)
- Females = 0.85 * (140-age (yrs) (body weight (kg)/(72)(serum creatinine (mg/dL)
- Bilirubin = 160, diastolic blood pressure >= 90
- Urine protein/creatinine ratio >= 1.0
- History of clinically significant hemorrhagic or thrombotic event within the past 6 months, not including uncomplicated catheter-associated venous thrombosis; patients on anti-coagulation are not permitted to be on any oral formulations (warfarin, rivaroxaban, dabigatran, etc.) due to concern for drug-drug interaction
- Unstable angina, symptomatic congestive heart failure or cardiac arrhythmia requiring anti-arrhythmic therapy (beta-blockers, calcium channel blockers and digoxin are allowed)
- History of cerebrovascular or myocardial ischemia within 6 months of initiation
- Known inherited predisposition to bleeding or thrombosis
- Known active or chronic hepatitis B or C or human immunodeficiency virus (HIV)
- Untreated brain metastases
- History of second primary malignancy diagnosed within 3 years prior to enrollment, excluding:
- In-situ cervical carcinoma
- Superficial bladder cancer
- Non-melanoma skin cancer
- Stage I breast cancer
- Low grade (Gleason = = grade 3 hand-foot syndrome, documented severe diarrhea requiring hospitalization, or other documented severe adverse events (AEs) attributable to capecitabine
- PHASE II: History of intolerance to capecitabine at doses below 1000 mg/m^2 BID, as defined by documented >= grade 3 hand-foot syndrome; documented severe diarrhea requiring hospitalization; or other documented severe AEs attributable to capecitabine
Data sourced from ClinicalTrials.gov (NCT02393755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.