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Phase II Trial of R115777 (NSC-702818), an Inhibitor of Farnesyl Protein Transferase, in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

Phase II Trial of R115777 (NSC-702818), an Inhibitor of Farnesyl Protein Transferase, in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma


OBJECTIVES:

I. Determine the safety and effectiveness of R115777 in patients with metastatic pancreatic
cancer.

II. Determine the response rate, time to progression, and 6 month survival rate of these
patients with this treatment regimen.

III. Assess the pharmacokinetics of this treatment regimen in this patient population.

OUTLINE: This is a multicenter study.

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

Patients are followed every 3 months for 1 year.

Inclusion Criteria


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)

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Neal J. Meropol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02335

NCT ID:

NCT00005843

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111