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

NCT00075647 | Completed Phase 2

• 4 other identifiers: NCI-2012-02567MDA-2003-0530N01CM17003CDR0000347405
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The method of Thall and Simon will be employed.

  6 months

Secondary Outcomes (6)

• Overall response rate defined as the number of patients who achieved CR or PR divided by the number of patients treated

  Up to 2 years

• Duration of response

  From the time of objective response to the time of progressive disease, assessed up to 2 years

• Time to progression (TTP)

  From the time of the study entry to the time of relapse or progression, assessed up to 2 years

• Systemic and local adverse events assessed using the established National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

  Up to 2 years

• Levels of PTEN, AKT, and PI3K

  Up to 2 years

Study Arms (1)

Treatment (temsirolimus)

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.

Drug: temsirolimus; Other: laboratory biomarker analysis

Interventions

temsirolimus DRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel

Treatment (temsirolimus)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (temsirolimus)

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

temsirolimus; Sirolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Henry Xiong

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

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: January 9, 2004
• First Posted: January 12, 2004
• Study Start: December 1, 2003
• Primary Completion: March 1, 2005
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

US (1)