Know Cancer

or
forgot password

A Phase III Trial Of ALIMTA Plus GEMZAR In Patients With Unresectable Or Metastatic Cancer Of The Pancreas


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

A Phase III Trial Of ALIMTA Plus GEMZAR In Patients With Unresectable Or Metastatic Cancer Of The Pancreas


OBJECTIVES:

- Compare the overall survival of patients with stage II, III, or IV unresectable
pancreatic cancer treated with gemcitabine with or without pemetrexed disodium.

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

- Compare the time to treatment failure and duration of response in patients treated with
these regimens.

- Compare tumor response rate in patients treated with these regimens.

- Compare the effects of these regimens on health-related quality of life in these
patients.

- Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, open-label, parallel, multicenter study. Patients are
stratified according to baseline ECOG performance status (0-1 vs 2), disease stage (II or
III vs IV), baseline homocysteine level (at least 12 ┬Ámol/L vs less than 12 ┬Ámol/L), and
participating center. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and
pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 3 weeks for up
to 8 courses in the absence of disease progression or unacceptable toxicity. Patients
also receive oral folic acid and cyanocobalamin intramuscularly every 9 weeks beginning
1-2 weeks before day 1 and continuing until 3 weeks after end of study therapy.

- Arm II: Patients receive gemcitabine IV over 30-60 minutes on days 1, 8, and 15.
Treatment repeats every 4 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed at baseline, at the end of each course, and then every 3 months
thereafter.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 520 patients (260 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Stage II, III, or IV disease that is not amenable to resection with curative
intent

- At least 1 bidimensionally measurable lesion with clearly defined margins by CT scan
or MRI or by palpation with both diameters at least 2 cm

- No clinically significant third-space fluid collection (e.g., ascites or pleural
effusions) NOTE: Fluid collections may be drained

- No documented brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

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

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

- Hemoglobin at least 9 g/dL

Hepatic

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

- AST/ALT no greater than 3 times ULN (5 times ULN if liver metastases present)

- Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases
present)

- Endoscopic or radiologic stenting allowed for biliary obstructions (bilirubin must
meet study requirements and AST/ALT and alkaline phosphatase must be no greater than
5 times ULN)

Renal

- Creatinine clearance at least 45 mL/min

Cardiovascular

- No unstable angina pectoris

Pulmonary

- See Disease Characteristics

Other

- No other malignancy within the past 5 years except carcinoma in situ of the cervix or
adequately treated nonmelanoma skin cancer

- No active infection

- No other serious concurrent systemic disorders that would preclude study

- No uncontrolled diabetes mellitus

- No weight loss of 10% or more within the past 6 weeks

- No inability or unwillingness to take folic acid or vitamin B12 supplementation

- Not pregnant or nursing

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy

- No prior biological therapy for pancreatic cancer

- No concurrent immunotherapy

- No concurrent routine colony-stimulating factors

- No concurrent stimulators of thrombopoiesis

Chemotherapy

- No prior chemotherapy for pancreatic cancer

- No prior fluorouracil for pancreatic cancer (including as a radiosensitizer)

- No other concurrent chemotherapy

Endocrine therapy

- No prior hormonal therapy for pancreatic cancer

- No concurrent hormonal therapy for cancer

Radiotherapy

- No prior radiation to whole pelvis

- Prior radiotherapy to less than 25% of bone marrow allowed

- At least 4 weeks since prior radiotherapy and recovered

- Concurrent palliative radiotherapy for small, painful metastases allowed

Surgery

- No concurrent surgery for cancer

Other

- At least 30 days since prior investigational agents or devices

- No other concurrent experimental medications (except thymidine)

- No other concurrent antitumor therapy

- No concurrent aspirin, salicylates, or other nonsteroidal anti-inflammatory drugs for
2-5 days before, during, and for 2 days after each dose of pemetrexed disodium

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Joanna M. Brell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000258097

NCT ID:

NCT00049426

Start Date:

July 2002

Completion Date:

Related Keywords:

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

Name

Location

Ireland Cancer Center Cleveland, Ohio  44106-5065