R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer

NCT00005843 | Completed Phase 2

• 4 other identifiers: NCI-2012-02335FCCC-00005NCI-45CDR0000067859
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Phase II trial to study the effectiveness of R115777 in treating patients who have metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: tipifarnib

Interventions

tipifarnib DRUG

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas * Measurable metastatic disease No prior treatment for metastatic disease except immunotherapy (e.g., antibodies, vaccines, cytokines) PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-2 * WBC at least 4,000/mm3 OR granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Bilirubin no greater than 2.0 mg/dL * SGOT/SGPT no greater than 2 times normal * Creatinine no greater than 2.0 mg/dL OR creatinine clearance at least 50 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after the study * No concurrent illness or active infection which would preclude study * No prior malignancy allowed unless disease free for the time period considered appropriate for cure of the specific cancer * No history of allergies to imidazole compounds (e.g., fluconazole, ketoconazole, miconazole, itraconazole, clotrimazole) PRIOR CONCURRENT THERAPY: * No prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or thrombopoietin * Primary neoadjuvant or adjuvant chemotherapy allowed at least 6 months prior to detection of metastatic disease * Primary radiotherapy allowed at least 6 months prior to detection of metastatic disease * No concurrent use of proton pump inhibitors (e.g., omeprazole)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• Cohen SJ, Ho L, Ranganathan S, Abbruzzese JL, Alpaugh RK, Beard M, Lewis NL, McLaughlin S, Rogatko A, Perez-Ruixo JJ, Thistle AM, Verhaeghe T, Wang H, Weiner LM, Wright JJ, Hudes GR, Meropol NJ. Phase II and pharmacodynamic study of the farnesyltransferase inhibitor R115777 as initial therapy in patients with metastatic pancreatic adenocarcinoma. J Clin Oncol. 2003 Apr 1;21(7):1301-6. doi: 10.1200/JCO.2003.08.040.

  PMID: 12663718 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Neal J. Meropol, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: March 5, 2004
• Study Start: May 1, 2000
• Primary Completion: September 1, 2004
• Last Updated: February 11, 2013

Record last verified: 2007-04

Locations

US (2)