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A Phase I Dose-Escalating Study of Induction Gemcitabine/Pemetrexed Followed by Pemetrexed and Concurrent Upper Abdominal Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer


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

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Trial Information

A Phase I Dose-Escalating Study of Induction Gemcitabine/Pemetrexed Followed by Pemetrexed and Concurrent Upper Abdominal Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of pemetrexed disodium when given in combination
with upper abdominal radiotherapy after induction therapy comprising gemcitabine
hydrochloride and pemetrexed disodium followed by consolidation therapy with
gemcitabine hydrochloride in patients with locally advanced pancreatic cancer.

- Determine the quantitative toxicity of this regimen in these patients.

Secondary

- Determine the quantitative and qualitative dose-limiting toxicities of pemetrexed
disodium in combination with upper abdominal radiation therapy.

- Evaluate patterns of failure, response, and survival of these patients at 1 year

OUTLINE: This is an open-label, nonrandomized, dose-escalation study of pemetrexed disodium.

- Induction therapy: Patients receive pemetrexed disodium IV over 10 minutes and
gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 14 days
for 3 courses. Approximately 2 weeks later, patients without disease progression
proceed to chemoradiotherapy.

- Chemoradiotherapy: Patients receive pemetrexed disodium IV over 10 minutes on days 1,
15, and 29 and undergo radiotherapy once daily 5 days a week for 5 ½ weeks.
Approximately 2-3 weeks later, patients without disease progression proceed to
consolidation therapy.

Cohorts of 3-9 patients receive escalating doses of pemetrexed disodium during
chemoradiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose at which ≤ 20% or ≤ 2 of 9 patients experience dose-limiting toxicity.

- Consolidation therapy: Patients receive gemcitabine hydrochloride IV over 30 minutes on
days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed carcinoma arising from the pancreas

- Stage II or III disease, meeting 1 of the following criteria:

- Nonresectable disease

- Potentially resectable disease

- Resectable disease

- Stage IV disease with symptomatic back pain requiring palliation allowed at the
discretion of the principal investigator

- Measurable, evaluable, or nonmeasurable disease

- No neuroendocrine tumor of the pancreas

- No documented brain metastasis

- No clinically significant pleural or peritoneal effusions that cannot be drained

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Life expectancy ≥ 12 weeks

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9 g/dL

- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver has tumor involvement)

- AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)

- Creatinine clearance ≥ 45 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment

- No active infection

- No serious systemic disorders that would preclude study treatment

- No significant cardiovascular disease in the form of abnormal electrocardiogram
coupled with clinical features of recent or recurrent cardiac disease (including
myocardial infarction, angina, or hypertension)

PRIOR CONCURRENT THERAPY:

- More than 4 weeks since prior investigational agents

- No prior chemotherapy for pancreatic cancer

- Must be able to discontinue aspirin, dexamethasone, and other nonsteroidal
anti-inflammatory agents for 2 days before, the day of, and 2 days after pemetrexed
disodium dose (5 days before for long-acting agents such as piroxicam)

- Must be able and willing to take folic acid and cyanocobalamin (vitamin B12)
supplementation

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

determine maximum tolerated dose of Premetrexed wehen given concurrently with gemcitabine

Outcome Time Frame:

42 days

Safety Issue:

Yes

Principal Investigator

Arthur William Blackstock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000466320

NCT ID:

NCT00310050

Start Date:

October 2005

Completion Date:

May 2008

Related Keywords:

  • Pancreatic Cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096