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A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231517, IND #40061) In the Treatment Of Recurrent Carcinoma Of The Cervix


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

Thank you

Trial Information

A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231517, IND #40061) In the Treatment Of Recurrent Carcinoma Of The Cervix


OBJECTIVES:

- Determine the antitumor activity of pemetrexed disodium in patients with recurrent
carcinoma of the cervix 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 22-60 patients will be accrued for this study within 1-2
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed carcinoma of the cervix

- Squamous cell or non-squamous cell

- Recurrent disease

- Progressive disease

- 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 disease progression is documented or a biopsy is obtained to confirm
persistence at least 90 days after completion of radiotherapy

- Not amenable to surgery, radiotherapy, or other therapy

- Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent
squamous cell or non-squamous cell carcinoma of the cervix

- Chemotherapy administered with primary radiotherapy as a radiosensitizer is not
considered a systemic chemotherapy regimen

- 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

- At least 24 hours since prior growth factors

- 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

- 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 for 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 for the malignant tumor

- No nonsteroidal anti-inflammatory drugs for 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:

CDR0000372923

NCT ID:

NCT00087113

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Cervical Cancer
  • cervical squamous cell carcinoma
  • recurrent cervical cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • stage IVB cervical cancer
  • Uterine Cervical Neoplasms

Name

Location

CCOP - Kansas CityKansas City, Missouri  64131
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Doctors Medical CenterModesto, California  95350
St. John's Regional Health CenterSpringfield, Missouri  65804
Women's Cancer Center - Las VegasLas Vegas, Nevada  89102
SUNY Downstate Medical CenterBrooklyn, New York  11203
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Hope A Women's Cancer CenterAsheville, North Carolina  28801
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Williamette Gynecologic Oncology P.C.Salem, Oregon  97301