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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Stage III Pancreatic Cancer

Stage IV Pancreatic Cancer

Stage II Pancreatic Cancer

Adenocarcinoma of the Pancreas

Recurrent Pancreatic Cancer

Treatments

Drug: temsirolimus

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

NIH

Identifiers

NCT00075647

NCI-2012-02567

N01CM17003 (U.S. NIH Grant/Contract)

CDR0000347405 (Registry Identifier)

MDA-2003-0530

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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