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


Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

Phase II Trial of CCI-779 in 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival (OS)

Outcome Description:

The method of Thall and Simon will be employed.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Henry Xiong

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02567

NCT ID:

NCT00075647

Start Date:

December 2003

Completion Date:

Related Keywords:

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

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030