S9924 R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005832
Recruitment Status : Completed
First Posted : April 26, 2004
Last Update Posted : November 17, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: R115777 Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Pancreas Cancer
Study Start Date : June 2000
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: R115777
300mg/dose BID, PO, Days 1-21, q 28days
Drug: R115777
300mg/dose BID, PO, Days 1-21, q 28days
Other Name: tipifarnib

Primary Outcome Measures :
  1. Survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Time to treatment failure [ Time Frame: Once every 8 weeks until progression ]
  2. Evaluate the frequency and severity of toxicities [ Time Frame: Weekly for 8 weeks and then once every 4 weeks ]
  3. Assess confirmed response (complete & partial) in patients with measurable advanced adenocarcinoma of the pancreas [ Time Frame: Once every 8 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005832

United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
University of California Davis Medical Center
Sacramento, California, United States, 95817
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 - Virginia Mason Research Center
Seattle, Washington, United States, 98101
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: John S. MacDonald, MD St. Vincent's Comprehensive Cancer Center - Manhattan

Publications of Results:
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.

Responsible Party: Southwest Oncology Group Identifier: NCT00005832     History of Changes
Other Study ID Numbers: CDR0000067846
S9924 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2004    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Southwest Oncology Group:
stage II pancreatic cancer
stage III pancreatic cancer
duct cell adenocarcinoma of the pancreas
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Agents
Antineoplastic Agents