- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005832
S9924 R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Pancreas Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have locally advanced or metastatic pancreatic cancer.
Study Overview
Detailed Description
OBJECTIVES: I. Determine the six month survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777. II. Determine the time to treatment failure and confirmed response in this patient population treated with this regimen. III. Evaluate the frequency and severity of toxicities associated with this treatment regimen in these patients.
OUTLINE: Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Martinez, California, United States, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Sacramento, California, United States, 95817
- University of California Davis Medical Center
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Illinois
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Kansas
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
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Missouri
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
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Ohio
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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South Carolina
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Greenville, South Carolina, United States, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Texas
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Galveston, Texas, United States, 77555-0209
- University of Texas Medical Branch
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Washington
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Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
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Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas Ductal adenocarcinoma Mucinous noncystic carcinoma Signet ring cell carcinoma Adenosquamous carcinoma Undifferentiated (anaplastic) carcinoma Mixed ductal endocrine carcinoma Well differentiated adenocarcinoma Moderately well or poorly differentiated adenocarcinoma Undifferentiated ductal carcinoma No papillary cystic carcinomas, sarcomas, or tumors arising from the endocrine pancreas Pathological confirmation of a metastatic site allowed Clinical documentation of pancreatic involvement and no evidence of another primary allowed Locally advanced or distant metastatic disease surgically incurable No known brain metastases
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Ability to swallow and/or receive enteral medications via gastrostomy feeding tube No intractable nausea or vomiting No other prior malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in remission Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent immunotherapy Chemotherapy: No prior chemotherapy No prior adjuvant or neoadjuvant chemoradiotherapy, including for advanced pancreatic cancer No other concurrent chemotherapy Endocrine therapy: No prior or concurrent hormonal therapy Radiotherapy: See Chemotherapy No prior radiotherapy, except for palliation to metastatic sites No concurrent radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior surgery for pancreatic cancer and recovered Prior partial resections of the stomach and duodenum for pancreatic cancer allowed No prior major resection of the small intestine Prior pancreaticduodenectomy for pancreatic cancer allowed Other: No concurrent proton pump inhibitors (e.g., omeprazole) Concurrent antacids or H2 blockers allowed No other concurrent therapy for pancreatic cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: R115777
300mg/dose BID, PO, Days 1-21, q 28days
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300mg/dose BID, PO, Days 1-21, q 28days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Time to treatment failure
Time Frame: Once every 8 weeks until progression
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Once every 8 weeks until progression
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Evaluate the frequency and severity of toxicities
Time Frame: Weekly for 8 weeks and then once every 4 weeks
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Weekly for 8 weeks and then once every 4 weeks
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Assess confirmed response (complete & partial) in patients with measurable advanced adenocarcinoma of the pancreas
Time Frame: Once every 8 weeks
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Once every 8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: John S. MacDonald, MD, St. Vincent's Comprehensive Cancer Center - Manhattan
Publications and helpful links
General Publications
- Macdonald JS, McCoy S, Whitehead RP, Iqbal S, Wade JL 3rd, Giguere JK, Abbruzzese JL. A phase II study of farnesyl transferase inhibitor R115777 in pancreatic cancer: a Southwest oncology group (SWOG 9924) study. Invest New Drugs. 2005 Oct;23(5):485-7. doi: 10.1007/s10637-005-2908-y.
- Macdonald JS, Chansky K, Whitehead R, et al.: A phase II study of farnesyl transferase inhibitor R115777 in pancreatic cancer. A Southwest Oncology Group (SWOG) study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-548, 2002.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067846
- U10CA032102 (U.S. NIH Grant/Contract)
- S9924 (Other Identifier: SWOG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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