Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	MDA-2003-0530 NCI-6182, NCT00075647, 6182

Objectives

Primary

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

Secondary

1. Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug.
2. Correlate biomarkers of response with clinical response in patients treated with this drug.
3. Determine the safety and toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Locally advanced or metastatic disease



• Radiographic evidence of disease



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent prophylactic hematopoietic colony-stimulating factors

Chemotherapy

• 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

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy

Surgery

• See Chemotherapy

Other

• 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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

• Creatinine ≤ 1.5 mg/dL

  OR

• Creatinine clearance ≥ 50 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Henry Xiong, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 713-792-6161; 800-392-1611
James Abbruzzese, MD, Protocol co-chair		Ph: 713-792-2828; 800-392-1611

Registry Information
Official Title		A Phase II Study of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer
Trial Start Date		2003-12-01
Registered in ClinicalTrials.gov		NCT00075647
Date Submitted to PDQ		2003-12-02
Information Last Verified		2005-02-08
NCI Grant/Contract Number		N01-CM17003, P30-CA16672

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