Clinical trial NCT00075647: CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Official title: Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 6 months
Secondary outcomes:
measure: Overall response rate defined as the number of patients who achieved CR or PR divided by the number of patients treated
timeFrame: Up to 2 years
measure: Duration of response
timeFrame: From the time of objective response to the time of progressive disease, assessed up to 2 years
measure: Time to progression (TTP)
timeFrame: From the time of the study entry to the time of relapse or progression, assessed up to 2 years
measure: Systemic and local adverse events assessed using the established National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: Up to 2 years
measure: Levels of PTEN, AKT, and PI3K
timeFrame: Up to 2 years
measure: Expression and phosphorylation status of p70s6k
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Henry Xiong
role: PRINCIPAL_INVESTIGATOR
References: