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A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma

Phase 3
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma


- Compare survival of patients with locally advanced or metastatic pancreatic cancer
treated with prolonged infusion gemcitabine with vs without oxaliplatin vs standard
infusion gemcitabine.

- Compare the toxicity of these regimens in these patients.

- Compare the objective response in patients treated with these regimens.

- Compare the patterns of failure and progression-free survival of patients treated with
these regimens.

- Compare the reported frequency of deep vein thrombosis and pulmonary embolism among
patients treated with these regimens.

- Compare the changes in quality of life, including improved symptom control and/or
additional side effects of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance
status (0 or 1 vs 2) and disease stage (locally advanced vs metastatic). Patients are
randomized to 1 of 3 treatment arms.

- Arm I (standard treatment): Patients receive gemcitabine IV over 30 minutes once weekly
for 7 weeks followed by 1 week of rest for course 1 only. In all subsequent courses,
patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, with courses
repeating every 4 weeks in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Courses
repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

- Arm III: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV
over 120 minutes on day 2. Courses repeat every 2 weeks in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed at baseline and then at 8 and 16 weeks.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 789 patients (263 per treatment arm) will be accrued for this
study within 18 months.

Inclusion Criteria


- Histologically or cytologically confirmed locally advanced or metastatic pancreatic
adenocarcinoma or poorly differentiated carcinoma

- Ineligible for curative resection

- Measurable and/or nonmeasurable disease

- Must have evidence of disease outside prior radiation fields OR radiologically
confirmed progression of disease within the radiation fields after completion of



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- WBC ≥ 3,500/mm^3 OR

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 125,000/mm^3


- Bilirubin < 2.0 mg/dL

- AST < 3 times upper limit of normal (ULN)


- Creatinine ≤ 1.5 times ULN


- No uncontrolled cardiac disease


- Not pregnant or nursing

- Negative pregnancy test

- Negative vaginal ultrasound for patients with an elevated beta human chorionic
gonadotropin level

- Fertile patients must use effective nonhormonal contraception

- No other malignancies within the past 5 years except nonmetastatic, nonmelanoma skin
cancer, carcinoma in situ of the cervix, or cancer cured by surgery or small field

- No active or uncontrolled infection

- No other active illness that would preclude study participation

- No symptomatic sensory peripheral neuropathy ≥ grade 2


Biologic therapy

- Not specified


- No prior chemotherapy for metastatic disease

- No prior (including adjuvant) gemcitabine or oxaliplatin

- Prior adjuvant chemotherapy allowed provided there was more than 6 months between the
last dose of adjuvant chemotherapy and recurrence of pancreatic cancer

- Prior chemotherapy as a radiosensitizing agent allowed* NOTE: *To the primary site

Endocrine therapy

- Not specified


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy to the primary tumor site and recovered

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


- See Disease Characteristics

- Prior surgical resection allowed


- No concurrent participation in supportive care trials

- Concurrent enrollment on protocol ECOG-E1Y03 allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Elizabeth A. Poplin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Federal Government

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



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