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A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma


Phase 2
N/A
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma


OBJECTIVES:

- Determine the antitumor activity of pemetrexed disodium in patients with persistent or
recurrent endometrial adenocarcinoma that failed higher priority treatment protocols.

- Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.

Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed
disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12)
intramuscularly every 9 weeks.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 1-3.4
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed endometrial adenocarcinoma

- Persistent or recurrent disease

- Refractory to curative or standard therapy

- Measurable disease

- At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional
techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by
spiral CT scan

- Tumors within a previously irradiated field are considered non-target lesions
unless progression is documented or biopsy is obtained to confirm persistence ≥
90 days after completion of radiotherapy

- Must have received 1 prior chemotherapy regimen for endometrial cancer

- Initial treatment may have included high-dose therapy, consolidation, or
extended therapy administered after surgical or non-surgical assessment

- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG
protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

- Any age

Performance status

- GOG 0-2

Life expectancy

- Not specified

Hematopoietic

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

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

Hepatic

- AST and ALT ≤ 3 times upper limit of normal (ULN)*

- Alkaline phosphatase ≤ 3 times ULN*

- Bilirubin ≤ 1.5 times ULN NOTE: * ≤ 5 times ULN if liver metastases are present

Renal

- Creatinine clearance ≥ 45 mL/min

Other

- Not pregnant

- Negative pregnancy test

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

- Neuropathy (sensory and motor) ≤ grade 1

- No active infection requiring antibiotics

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 3 weeks since prior biologic or immunologic agents for the malignant tumor

- One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent
disease allowed, including, but not limited to, the following:

- Monoclonal antibodies

- Cytokines

- Small-molecule inhibitors of signal transduction

- At least 24 hours since prior growth factors

- No concurrent routine colony-stimulating factors

Chemotherapy

- See Disease Characteristics

- Recovered from prior chemotherapy

- No more than 1 prior cytotoxic chemotherapy regimen with either single or combination
cytotoxic drug therapy

- No prior pemetrexed disodium

Endocrine therapy

- At least 1 week since prior hormonal therapy directed at the malignant tumor

- Concurrent hormone replacement therapy allowed

Radiotherapy

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy and recovered

- No prior radiotherapy to ≥ 25% of bone marrow

Surgery

- Recovered from prior surgery

Other

- At least 3 weeks since other prior therapy directed at the malignant tumor

- No nonsteroidal anti-inflammatory drugs 2-5 days before, during, and for 1-2 days
after study drug administration

- Concurrent daily low-dose (≤ 325 mg/day) aspirin therapy allowed

- No prior therapy that would contraindicate study participation

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:

No

Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000372921

NCT ID:

NCT00087100

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • endometrial adenocarcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

CCOP - Carle Cancer CenterUrbana, Illinois  61801
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Avera Cancer InstituteSioux Falls, South Dakota  57105
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
SUNY Downstate Medical CenterBrooklyn, New York  11203
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Alamance Cancer Center at Alamance Regional Medical CenterBurlington, North Carolina  27216