Completed

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

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What is being tested

temsirolimus

+ laboratory biomarker analysis
Drug
Other
Who is being recruted

Adenocarcinoma of the Pancreas
+2

+ Recurrent Pancreatic Cancer
+ Stage II Pancreatic Cancer
Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2003

See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 17, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual date on which the first participant was enrolled.

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 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.

Official TitlePhase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer 
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 17, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Study Objectives
Primary Objectives

The method of Thall and Simon will be employed.
Secondary Objectives

95% confidence interval will be presented

Descriptive statistics (mean, standard deviation, median, and range) will be displayed for relevant laboratory parameters.

Expression levels will be correlated with patient survival duration using Cox proportional hazard regression analysis

Descriptive statistics will be applied to report the mean, duration of the effects on p70s6k phosphorylation.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
M D Anderson Cancer CenterHouston, United StatesSee the location
CompletedOne Study Center