CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

NCT ID: NCT00075647

Last Updated: 2013-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31

Brief Summary

Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779.

SECONDARY OBJECTIVES:

I. Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug.

II. Correlate biomarkers of response with clinical response in patients treated with this drug.

III. Determine the safety and toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.

Conditions

Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (temsirolimus)

Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

temsirolimus

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

temsirolimus

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CCI-779; cell cycle inhibitor 779; Torisel

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• Locally advanced or metastatic disease
• Radiographic evidence of disease
• No known brain metastases
• Performance status - ECOG 0-2
• More than 3 months
• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
• Creatinine ≤ 1.5 mg/dL
• Creatinine clearance ≥ 50 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Fasting serum cholesterol ≤ 350 mg/dL
• Fasting triglycerides ≤ 400 mg/dL
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other concurrent uncontrolled illness
• No concurrent prophylactic hematopoietic colony-stimulating factors
• No prior chemotherapy for metastatic pancreatic cancer
• More than 2 months since prior adjuvant or neoadjuvant chemoradiotherapy for resected pancreatic cancer

• Must have radiographic evidence of recurrent disease
• More than 2 months since prior chemoradiotherapy for locally advanced pancreatic cancer

• Must have radiographic evidence of disease progression
• See Chemotherapy
• See Chemotherapy
• No other concurrent investigational or commercial agents or therapies for the malignancy
• No other concurrent anticancer therapy
• No concurrent combination antiretroviral therapy for HIV-positive patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Xiong

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-2003-0530

Identifier Type: -

Identifier Source: secondary_id

N01CM17003

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000347405

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02567

Identifier Type: -

Identifier Source: org_study_id