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A Randomized Phase I/II Study With Gemcitabine and RTA 402 or Gemcitabine and Placebo for Patients With Unresectable Pancreatic Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms, Pancreatic Cancer

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Trial Information

A Randomized Phase I/II Study With Gemcitabine and RTA 402 or Gemcitabine and Placebo for Patients With Unresectable Pancreatic Cancer


Phase I will be conducted to determine the MTD of RTA 402 (administered orally Days 1-21 or
Days 1-28 of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will
be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle.

The phase II portion of the study will be randomized, and double-blinded. Phase II will
utilize the RTA 402 MTD determined in Phase I; Arm 1 will consist of gemcitabine + RTA 402.
RTA 402 capsules will administered orally Days 1-21 of each 28-day cycle (or Days 1-28 if
appropriate, based on phase I results); gemcitabine (1000 mg/m2) will be administered as an
intravenous infusion on Days 1, 8, and 15 of each 28-day cycle in each Arm. Arm 2 will
consist of gemcitabine + placebo, placebo capsules will be taken orally Days 1-21 of each
28-day cycle (or Days 1-28 if appropriate, based on phase I results). Both treatment arms
are 4-weeks in length.


Inclusion Criteria:



- Phase I patients should have treatment naïve pancreatic cancer; however , Phase I
patients who have had 1 prior regimen consisting of adjuvant chemo-radiation or
adjuvant gemcitabine - as defined within the NCCN guidelines may be enrolled. Phase
II patients must have metastatic disease (Stage IV only).

- Karnofsky performance status of >70%

- Adequate liver function. (total bilirubin ≤ 1.5 mg/dL and AST(SGOT) and ALT(SGPT) of
< 2.5 ULN ( ≤ 5 ULN for Phase II patients with liver metastases), Serum Creatinine <
1.5 ULN

- Adequate bone marrow function as documented by the following laboratory test results
within 14 days of starting therapy. platelets ≥100,000/mm3, absolute neutrophil count
(ANC) ≥1500/mm3, hemoglobin ≥9.0 g/dL, white blood cell (WBC) count ≥3000 /mm3

- Practice effective contraception during the entire study period.

- Life expectancy of more than 3 months.

- Able and willing to sign the informed consent form.

- Willing and able to self-administer orally and document all doses of RTA 402
ingested.

Exclusion Criteria:

- Prior treatment for current malignancy outside of the adjuvant setting for Phase I

- Inability to swallow tablets or capsules

- Active brain metastases or primary central nervous system (CNS) malignancies.
(Patients with a previously treated brain metastasis may be included.)

- Active second malignancy

- Ten percent or greater weight loss over the 6 weeks before study entry.

- Pregnant or breast feeding

- Clinically significant illnesses which could compromise participation in the study,
including, but not limited to: Uncontrolled diabetes; Active or uncontrolled
infection; Acute or chronic liver disease; Confirmed diagnosis of Human
immunodeficiency virus (HIV) infection; Uncontrolled hypertension, symptomatic
congestive heart failure, unstable angina pectoris, myocardial infarction within the
past 6 months, or uncontrolled cardiac arrhythmia.

- Psychiatric illness that would limit compliance with study requirements.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Phase I - To determine the maximum tolerated dose (MTD) of RTA 402 in combination with gemcitabine in patients with locally advanced or metastatic pancreatic cancer.

Outcome Time Frame:

End of trial

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

402-C-0702

NCT ID:

NCT00529113

Start Date:

March 2007

Completion Date:

December 2008

Related Keywords:

  • Pancreatic Neoplasms
  • Pancreatic Cancer
  • pancreatic cancer
  • gemcitabine
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location

University of Texas Southwestern Medical CenterDallas, Texas  
Mary Crowley Cancer Research CenterDallas, Texas  75246
Rocky Mountain Cancer Center (US Oncology)Denver, Colorado  
Cancer Centers of Florida (US Oncology)Ocoee, Florida  
Central Indiana Cancer Centers (US Oncology)Indianapolis, Indiana  
Iowa Blood and Cancer Care (Mary Crowley Cancer Research Center)Cedar Rapids, Iowa  52402
Billings Clinic (Mary Crowley Cancer Research Center)Billings, Montana  59101
Sammons Cancer Center (US Oncology)Dallas, Texas  75246
Northwest Cancer Specialist- Vancouver Cancer Specialist (US Oncology)Vancouver, Washington