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

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00005832

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

4.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

N/A

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 :

Jun 1, 2000

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Arms and Interventions

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 Names: tipifarnib

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 Names:

tipifarnib

Outcome Measures

Primary Outcome Measures

Survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777 [6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	USC/Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033-0800
2	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California	United States	94553
3	University of California Davis Medical Center	Sacramento	California	United States	95817
4	CCOP - Central Illinois	Decatur	Illinois	United States	62526
5	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
6	Veterans Affairs Medical Center - Wichita	Wichita	Kansas	United States	67218
7	CCOP - Kansas City	Kansas City	Missouri	United States	64131
8	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
9	CCOP - Columbus	Columbus	Ohio	United States	43206
10	CCOP - Greenville	Greenville	South Carolina	United States	29615
11	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
12	University of Texas Medical Branch	Galveston	Texas	United States	77555-0209
13	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
14	CCOP - Northwest	Tacoma	Washington	United States	98405-0986