S-1 and Bevacizumab in Treating Patients With Colorectal Cancer That is Recurrent or Cannot Be Removed by Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Osaka Medical College
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00974389
First received: September 9, 2009
Last updated: October 28, 2010
Last verified: September 2009
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Purpose
RATIONALE: Drugs used in chemotherapy, such as S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving S-1 together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving S-1 together with bevacizumab works as third-line therapy in treating patients with colorectal cancer that is recurrent or that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: bevacizumab Drug: tegafur-gimeracil-oteracil potassium |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Combination Chemotherapy With S-1 Plus Avastin in Unresectable or Recurrent Colorectal Cancer After Failure of Prior Chemotherapy, Including Irinotecan and Oxaliplatin Regimens. |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Disease-control rate [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To evaluate giving S-1 with bevacizumab to see how well it works as third-line therapy in KRAS-mutation patients with unresectable or recurrent colorectal cancer.
OUTLINE: Patients receive oral S-1 twice daily on days 1-28 and bevacizumab IV on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal carcinoma
- Inoperable, locally advanced, or metastatic disease
- KRAS-mutated
- Concurrently receiving treatment containing irinotecan and oxaliplatin regimens for unresectable or recurrent colorectal cancer
- Measurable disease according to RECIST
- No moderate or severe ascites or pleural effusion requiring treatment
- No metastasis to the CNS
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- White blood cell count > 3,500/mm³ but < 12,000/mm³
- Neutrophil count > 1,500/mm³
- Hemoglobin > 9.0 g/dL
- Platelet count > 100,000/mm³
- Total bilirubin < 1.5 mg/dL
- AST and ALT < 100 U/L (< 200 U/L in patients with liver metastasis)
- Serum creatinine < 1.2 mg/dL
- Creatinine clearance ≥ 50 mL/min
- Urine dipstick for proteinuria < 1+
- INR < 1.5
- Not pregnant or nursing
- Able to take capsules orally
- No active second cancer
- No active infections (e.g., patients with pyrexia of ≥ 38°C)
- No serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, poorly controlled diabetes, or hypertension)
- No electrocardiographic abnormalities with cardiac disorder that would clinically preclude the execution of the study as judged by the investigator
- No serious drug hypersensitivity or a history of drug allergy
- No thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
- No history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- No clinically significant traumatic injury within the past 4 weeks
- No severe mental disorder
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent low-dose aspirin therapy (< 325 mg/day) allowed
- More than 4 weeks since prior major surgical procedure or open biopsy
- No prior therapy radiotherapy
- No prior therapy with S-1
- No prior chemotherapy include irinotecan and oxaliplatin as first- or second-line treatment.
- No concurrent continuous treatment with steroids
- No concurrent treatment with flucytosine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974389
Locations
| Japan | |
| Osaka Medical College | Recruiting |
| Takatsuki, Osaka, Japan, 569-8686 | |
| Contact: Hiroya Takiuchi, MD, PhD 81-72-683-1221 | |
Sponsors and Collaborators
Osaka Medical College
Investigators
| Principal Investigator: | Hiroya Takiuchi, MD, PhD | Osaka Medical College |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00974389 History of Changes |
| Other Study ID Numbers: | CDR0000649021, OSAKA-TRICC0901 |
| Study First Received: | September 9, 2009 |
| Last Updated: | October 28, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage III colon cancer stage III rectal cancer stage IV colon cancer |
stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Tegafur S 1 (combination) |
Bevacizumab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013