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R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
This study is ongoing, but not recruiting participants.
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005832
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: tipifarnib
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Pancrelipase R 115777 Tipifarnib Ultrase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Pancreas Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005832

Locations
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43206
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: John S. MacDonald, MD St. Vincent's Comprehensive Cancer Center - Manhattan
  More Information

Additional Information:
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.
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 ID Numbers: CDR0000067846, SWOG-S9924
Study First Received: June 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005832     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer
stage III pancreatic cancer
duct cell adenocarcinoma of the pancreas
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Adenocarcinoma
Pancrelipase
Tipifarnib
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Antineoplastic Agents
Therapeutic Uses
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Pharmacologic Actions
Tipifarnib
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009