GV1001 combination therapy in metastatic colorectal cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0003776
- Lead Sponsor
- Hallym University Medical Center
- Brief Summary
From May 13, 2015 to October 13, 2020, a total of 56 patients with recurrent or metastatic colorectal cancer were enrolled in this study. The patients had a median age of 64 (range, 29-82) and 67.9% of the patients were male. 66.1% of the patients had left-side colorectal cancer and RAS mutation was identified in 25%. Of all patients, 12 patients who did not undergo at least one cycle of treatment or tumor assessment were excluded from the efficacy analysis. In modified intention-to-treat population, disease control rate and objective response rate were 90.9% (95% Confidence interval [CI], 82.4-99.4) and 34.1% (95% CI, 20.1-48.1), respectively. The median progression free survival was 7.1 months (95% CI, 5.2- 9.1) and the median overall survival was 12.8 months (95% CI, 9.9-15.8). Most common all-grade adverse events were neutropenia (48.2%), nausea (26.8%), neuropathy (25.0%), stomatitis (21.4%), diarrhea (21.4%) and grade 3 or higher adverse events were neutropenia (16.1%), nausea (7.1%) and vomiting (7.1%).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 55
1. Histologically or cytologically confirmed metastatic colorectal cancer patients eligible for 2nd line palliative chemotherapy
2. Patients who have measurable disease as defined by Response Evaluation Criteria In Solid Tumors Guideline version 1.1 (RECIST 1.1) (No prior radiation therapy to measurable lesion)
3. Patients who failed 1st line chemotherapy or recurred during adjuvant chemotherapy or recurred within 6 months of completion of adjuvant chemotherapy
4. Age = 19 years
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Life expectancy = 12 weeks
7. Adequate hematopoietic function (hemoglobin = 9.0 g/dL; absolute neutrophil count = 1,500/µL; platelet count = 100,000/µL)
8. Adequate hepatic function (total bilirubin < 2.5xULN, transaminase < 2.5xULN, < 5xULN, if liver metastases are present)
9. Adequate renal function (serum creatinine = 1.5 mg/dL, or creatinine clearance = 50 mL/min)
10. Patients should sign a written informed consent before study entry
. Exclusion criteria
1. Other malignancy within the past 5 years except cured non-melanomatous skin cancer or carcinoma in situof the cervix.
2. History of clinically significant heart disease within the past 12 months (eg, refractory congestive heart failure, symptomatic coronary artery diseases, arrhythmia, myocardial infarction).
3. Serious concurrent infection requiring antibiotics.
4. Pregnant or breastfeeding women.
5. Patients with evidence of CNS metastasis. Patients with uncontrolled seizure or CNS disorder or psychiatric disorder.
6. History of allogenic transplantation (eg, kidney, liver transplantation)
7. Patient or caregiver who does not understand or consent to the written consent.
8. Patients receiving a concomitant treatment with drugs interacting with study drug.
9. Patients who have allergy to study drug.
10. Patients with malabsorption syndrome based on domestic authorization of the study drug.
11. Patients who need to take medication that affects the immune response (eg, long-term steroid administration or other immunosuppressants). However, short-term steroid usage for symptom relief associated with cancer is permissible.
12. Patients who participated in other clinical trials within 4 weeks before enrollment and taking other clinical trial drugs.
13. Patients who received radiation therapy within 8 weeks prior to enrollment.
14. Patients who have been identified not to be suitable for the study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease control rate
- Secondary Outcome Measures
Name Time Method Response rate;Progression-free survival;Overall survival;Immune response