RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
This study has been completed.
Sponsor:
Asan Medical Center
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00729482
First received: August 4, 2008
Last updated: August 1, 2012
Last verified: August 2012
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Purpose
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%.
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Neoplasm |
Drug: RAD001 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer |
Resource links provided by NLM:
Further study details as provided by Asan Medical Center:
Primary Outcome Measures:
- progression-free survival rate at 4-month (16 weeks) [ Time Frame: 4 months (16 weeks) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- response rate [ Time Frame: 2years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Toxicity profiles (according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 54 |
| Study Start Date: | July 2008 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Treatment Arm (RAD001)
|
Drug: RAD001
RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability
Other Name: everolimus
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Yoon-Koo Kang, Professor, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT00729482 History of Changes |
| Other Study ID Numbers: | AMC0702 |
| Study First Received: | August 4, 2008 |
| Last Updated: | August 1, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Asan Medical Center:
|
RAD001 (everolimus) second-line treatment advanced gastric cancer |
Additional relevant MeSH terms:
|
Neoplasms Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Everolimus Sirolimus |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013