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

Stage IV Pancreatic Cancer Clinical Trial

Official title:

Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075647
• Other study ID #: NCI-2012-02567
• Secondary ID: MDA-2003-0530N01
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2004
• Last updated: January 16, 2013
• Start date: December 2003

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Pancreas
• Pancreatic Neoplasms
• Recurrent Pancreatic Cancer
• Stage II Pancreatic Cancer
• Stage III Pancreatic Cancer
• Stage IV Pancreatic Cancer

Intervention

Drug:
• temsirolimus
Given IV

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	The method of Thall and Simon will be employed.	6 months	No
Secondary	Overall response rate defined as the number of patients who achieved CR or PR divided by the number of patients treated	95% confidence interval will be presented	Up to 2 years	No
Secondary	Duration of response		From the time of objective response to the time of progressive disease, assessed up to 2 years	No
Secondary	Time to progression (TTP)		From the time of the study entry to the time of relapse or progression, assessed up to 2 years	No
Secondary	Systemic and local adverse events assessed using the established National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)	Descriptive statistics (mean, standard deviation, median, and range) will be displayed for relevant laboratory parameters.	Up to 2 years	Yes
Secondary	Levels of PTEN, AKT, and PI3K	Expression levels will be correlated with patient survival duration using Cox proportional hazard regression analysis	Up to 2 years	No
Secondary	Expression and phosphorylation status of p70s6k	Descriptive statistics will be applied to report the mean, duration of the effects on p70s6k phosphorylation.	Up to 7 days	No