Stomach Neoplasm
Conditions
Keywords
RAD001 (everolimus), second-line treatment, advanced gastric cancer
Brief summary
This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free survival rate (primary end-point) and response rate, toxicity, and overall survival (secondary end-points) in patients with metastatic and/or advanced inoperable gastric cancer. Eligibility criteria include histologically proven gastric/gastroesophageal junction cancer who failed previous first-line standard treatment with fluoropyrimidine and platinum-based chemotherapy. Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted according to the observed clinical toxicities. Treatment will be continued until disease progression or patient's intolerability to the study drug. Total of 54 patients will be enrolled to decide whether the proportion of patients who are free from progression at 4 months (16 weeks), P, is less that or equal to 0.15 or greater than or equal to 0.30 to assess the treatment outcome in 48 patients assuming drop-out rate, 10%.
Interventions
DRUGRAD001
RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction * Patients must have non-resectable disease by metastasis or recurrent disease after curative surgical resection with uni-dimensionally measurable disease (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination) * Patients tumor should have failure of 1st line chemotherapy including fluoropyrimidine (5-FU, capecitabine, doxifluridine, S1, or UFT) and platinum (cisplatin, carboplatin, or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy * Age 18 to 75 years old * Estimated life expectancy of more than 3 months * ECOG performance status of 2 or lower * Adequate bone marrow function * Adequate kidney function * Adequate liver function * No prior radiation therapy to more than 25 percent of BM * Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study * Women of childbearing potential must have a negative pregnancy test on admission * The patient must be able to understand the study and has given written informed consent to participate in the study
Exclusion criteria
* Other tumor types than adenocarcinoma * Central nervous system metastases or prior radiation for CNS metastasis * Gastric outlet obstruction or intestinal obstruction * Evidence of active gastrointestinal bleeding * Bony metastasis as the sole evaluable disease * Past or concurrent history of neoplasm other than stomach cancer * Pregnant or lactating women, women of childbearing potential not employing adequate contraception * Thyroid disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival Rate at 4-month (16 Weeks) | 4 months (16 weeks) | progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 2years | Tumor response is evaluated according to the new guidelines by RECIST criteria (See Appendix D). A complete response (CR) is defined as the disappearance of all evidence of cancer for 4 weeks or longer. A partial response (PR) is defined as a 30% or more reduction in the sum of the longest diameters of target lesions for 4 weeks or longer without any evidence of new lesions or progression of any lesions. Stable disease is defined as less than a 30% reduction or less than a 20% increase in the longest diameters of target lesions without any evidence of new lesions. Progressive disease is defined as a more than 20% increase in one or more lesions or the appearance of any new lesion. |
| Overall Survival | 1 year | — |
| Number of Participants With Adverse Events | up to 24 weeks | (according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0) |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RAD001 Treatment Arm (RAD001) | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | RAD001 |
|---|---|
| Age, Customized | 57.5 years |
| Region of Enrollment Korea, Republic of | 54 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 54 / 54 |
| serious Total, serious adverse events | 5 / 54 |
Outcome results
Primary
Progression-free Survival Rate at 4-month (16 Weeks)
progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion
Time frame: 4 months (16 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAD001 | Progression-free Survival Rate at 4-month (16 Weeks) | 18.4 percentage of participants |
Secondary
Number of Participants With Adverse Events
(according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0)
Time frame: up to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAD001 | Number of Participants With Adverse Events | 54 participants |
Secondary
Overall Survival
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RAD001 | Overall Survival | 8.3 Months |
Secondary
Response Rate
Tumor response is evaluated according to the new guidelines by RECIST criteria (See Appendix D). A complete response (CR) is defined as the disappearance of all evidence of cancer for 4 weeks or longer. A partial response (PR) is defined as a 30% or more reduction in the sum of the longest diameters of target lesions for 4 weeks or longer without any evidence of new lesions or progression of any lesions. Stable disease is defined as less than a 30% reduction or less than a 20% increase in the longest diameters of target lesions without any evidence of new lesions. Progressive disease is defined as a more than 20% increase in one or more lesions or the appearance of any new lesion.
Time frame: 2years
Population: 51 patients were available for response assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAD001 | Response Rate | 3.7 percentage of participants |