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A Randomized Phase II Open-Label Study of Two Different Dose Levels of PX-12 in Patients With Advanced Carcinoma of the Pancreas Whose Tumors Have Progressed on Gemcitabine or on a Gemcitabine-Containing Combination


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

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Trial Information

A Randomized Phase II Open-Label Study of Two Different Dose Levels of PX-12 in Patients With Advanced Carcinoma of the Pancreas Whose Tumors Have Progressed on Gemcitabine or on a Gemcitabine-Containing Combination


In a Phase I trial, PX-12 demonstrated anti-tumor activity and pharmacodynamic activity
across a wide dose range. At higher doses, one side effect of the agent was a garlic-like
odor of an expired metabolite. This study is being conducted to evaluate the clinical
efficacy, biologic activity (inhibition of PX-12 target thioredoxin-1) and effects of the
expired metabolite at two dose levels of PX-12. This study will determine if the efficacy
and biologic activity achieved at either of the two dose levels is sufficient to proceed to
further studies without pushing to the maximally tolerated dose.


Inclusion Criteria:



- Histologically- or cytologically-confirmed diagnosis of advanced carcinoma of the
pancreas (stage IV disease only).

- Patients whose tumor has progressed on gemcitabine or on a gemcitabine-containing
combination. Patients must have received no more than two prior regimens for
metastatic disease. Use of gemcitabine as a radiation sensitizer in combination with
radiotherapy for localized disease will not be considered a prior
gemcitabine-containing regimen if gemcitabine was received for ≤ 1 month following
completion of radiotherapy. In addition, the use of 5-fluorouracil as a radiation
sensitizer for localized disease will be allowed and not counted as a prior regimen
if the 5-FU was continued for ≤ 1month following completion of radiotherapy.

- Karnofsky Performance Status of ≥ 70%.

- Patients must have discontinued previous anti-cancer therapy or other investigational
agent at least three weeks or within 5 half lives of the drug (whichever is shorter)
prior to entry into the study (six weeks for mitomycin C or nitrosureas) provided
that all toxicities from prior treatment have resolved to a Grade 1 or less.

- Patients must have discontinued radiation therapy at least two weeks prior to entry
into the study and have recovered from all radiation-related toxicities.

- Adequate organ function including the following:

- ANC ≥ 1500 cells/microL; platelets > 100,000/microL; hemoglobin ≥ 9 g/dL (may be
transfused to this level).

- Bilirubin ≤ 2.0 mg/dL; aspartate transaminase (AST/SGOT) and alanine transaminase
(ALT/SGPT) ≤ 3.0 times institutional upper limit of normal (ULN) OR < 5 times
institutional ULN if the subject has documented liver metastases.

- Creatinine ≤2.0 mg/dL.

- CA19-9 level >2 times ULN.

- Disease that is measurable by CT scan per RECIST criteria (Appendix IV).

- PET/CT or PET scan with SUV of ≥ 5.0 in at least one lesion on an 18F FDG scan.

Exclusion Criteria:

- Active infection requiring antibiotics at study entry.

- Any serious concomitant systemic disorder that in the opinion of the investigator
would place the patient at excessive or unacceptable risk of toxicity.

- Patients with active (requiring continuous medical therapy) pulmonary disease (COPD,
asthma) or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline
chest X-ray or PET/CT scan.

- Significant central nervous system or psychiatric disorder(s) that preclude the
ability of the patient to provide informed consent.

- Known or suspected brain metastases that have not received adequate therapy.
Patients must be stable without requirement for steroids or seizure medications.

- Major surgery within 4 weeks of study entry.

- Chemotherapy/investigational drugs within 3 weeks or within 5 half lives of the drug
(whichever is shorter) of study entry, provided that all toxicities from prior
treatment have resolved to a Grade 1 or less.

- Inability to tolerate prophylactic (1 mg/day) coumadin.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival and overall survival (percentage of patients alive at 6 months)

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

PX-12-II-01

NCT ID:

NCT00417287

Start Date:

December 2006

Completion Date:

April 2009

Related Keywords:

  • Pancreatic Neoplasms
  • Pancreas
  • Cancer
  • Carcinoma
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location

The University of Texas M.D. Anderson Cancer CenterHouston, Texas  
Arizona Cancer Center, University of ArizonaTucson, Arizona  85724-5081
TGen Clinical Research Services at Scottsdale HealthcareScottsdale, Arizona  85258