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A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Pancreas Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Pancreas Cancer

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.

Inclusion 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

John S. MacDonald, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Vincent's Comprehensive Cancer Center - Manhattan


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

October 2005

Related Keywords:

  • Pancreatic Cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • duct cell adenocarcinoma of the pancreas
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
University of California Davis Medical Center Sacramento, California  95817
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