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A Randomized Phase II Trial of PS-341 and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma

Phase 2
18 Years
Not Enrolling
Duct Cell Adenocarcinoma of the Pancreas, Stage IV Pancreatic Cancer

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Trial Information

A Randomized Phase II Trial of PS-341 and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma


I. Compare the objective response rate in previously untreated patients with metastatic
pancreatic adenocarcinoma treated with bortezomib with or without gemcitabine.

II. Compare the toxicity of these regimens in these patients. III. Compare the
progression-free, 6-month, and overall survival of patients treated with these regimens.

IV. Compare the change in overall quality of life (QOL) and in subcomponents of QOL of
patients after treatment with 2 consecutive courses of these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1of 2 treatment arms.

ARM I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients
with progressive disease crossover to arm II.

ARM II: Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1
and 8.

Courses in both arms repeat every 3 weeks in the absence of disease progression or
unacceptable toxicity.

Quality of life (QOL) is assessed at baseline and before courses 2 and 4. Patients who
crossover to arm II from arm I complete QOL questionnaires before the first 2 courses of arm
II therapy.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Inclusion Criteria:

- Histologically confirmed metastatic ductal or undifferentiated adenocarcinoma
consistent with a pancreatic primary for which no standard curative measures exist

- No locally advanced disease only

- No islet cell, acinar cell, or cystadenocarcinomas

- Measurable disease

- At least one lesion whose longest diameter can be accurately measured as 2 cm
or greater by conventional techniques OR 1 cm or greater by spiral CT scan

- A tumor lesion in a previously irradiated area allowed provided it is
histologically confirmed disease with radiographic progression from a
post-radiotherapy CT scan

- No CNS metastasis

- Performance status - ECOG 0-2

- At least 3 months

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL

- Bilirubin no greater than 1.5 times upper limit of normal (ULN) (stents allowed)

- AST no greater than 5 times ULN

- PT and PTT no greater than ULN*

- Creatinine no greater than 1.5 times ULN

- No other prior malignancy within the past 5 years except basal cell or squamous cell
skin cancer or carcinoma in situ of the cervix

- No neuropathy greater than grade 1

- No underlying disease state associated with active bleeding

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study

- More than 4 weeks since prior biologic therapy or immunotherapy

- No concurrent immunotherapy

- No concurrent colony-stimulating factors during the first course of the study

- No prior gemcitabine (even as a radiosensitizing agent)

- No prior chemotherapy

- Radiosensitizing agent as adjuvant therapy or for locally advanced disease

- No other concurrent chemotherapy

- See Disease Characteristics

- More than 4 weeks since prior radiotherapy

- No prior radiotherapy to 25% or more of the bone marrow

- No concurrent radiotherapy

- No prior bortezomib

Type of Study:


Study Design:

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

Outcome Measure:

Confirmed tumor response (CR, PR) rate in 2 consecutive courses within 6 months (Arm I)

Outcome Description:

An evaluable patient will be classified as a treatment 'success' if they have a confirmed tumor response (CR, PR). The proportion of successes will be estimated by the total number of evaluable patients. 95% confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.

Outcome Time Frame:

Up to 6 months

Safety Issue:


Principal Investigator

Steven Alberts

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • Duct Cell Adenocarcinoma of the Pancreas
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



North Central Cancer Treatment Group Rochester, Minnesota  55905