Know Cancer

forgot password

A Limited Access Phase II Trial of Pemetrexed (Alimta, LY231514) (NSC #698037) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

Phase 2
Open (Enrolling)
Cervical Cancer

Thank you

Trial Information

A Limited Access Phase II Trial of Pemetrexed (Alimta, LY231514) (NSC #698037) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix



- To estimate the antitumor activity of pemetrexed disodium and cisplatin with objective
tumor response (partial and complete response) in patients with advanced, persistent,
or recurrent carcinoma of the cervix.

- To determine the nature and degree of toxicity of this regimen in these patients.


- To determine the effects of this regimen on progression-free survival and overall

OUTLINE: This is a multicenter study. Patients are stratified according to prior cisplatin
therapy as a radiosensitizer (yes vs no).

Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1-4 hours on
day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria


- Histologically confirmed squamous or nonsquamous cell carcinoma of the cervix

- Advanced, persistent, or recurrent disease

- Disease not amenable to curative therapy

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques or ≥ 10 mm by spiral CT scan

- Must have ≥ 1 target lesion to be used to assess response

- Tumors within a previously irradiated field will be designated as "non-target"
lesions unless progression is documented or a biopsy is obtained to confirm
persistence ≥ 90 days following completion of radiotherapy


- GOG performance status 0-2

- Platelet count ≥ 100,000/mm^3

- ANC ≥ 1,500/mm^3

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Creatinine clearance ≥ 60 mL/min

- SGOT ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)

- Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)

- Negative pregnancy test

- Fertile patients must use effective contraception

- Neuropathy (sensory and motor) ≤ grade 1

- Able to take folic acid, vitamin B12, and dexamethasone according to study protocol

- No history of other invasive malignancies within the past 5 years, except nonmelanoma
skin cancer

- No active infection requiring antibiotics

- No presence of third space fluid which cannot be controlled by drainage


- Recovered from effects of recent surgery, radiotherapy, or other therapy

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

- At least 4 weeks since prior radiotherapy

- More than 3 years since prior radiotherapy for localized cancer of the breast, head
and neck, or skin and patient remains free of recurrent or metastatic disease

- No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the
treatment of cervical cancer

- No prior radiotherapy to more than 25% of marrow-bearing areas

- No prior cancer treatment that contraindicates study treatment

- No prior cytotoxic drugs for advanced or recurrent carcinoma of the cervix

- Prior cisplatin as a radiosensitizer for primary treatment of disease allowed

- No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2-5 days before,
during, or for 2 days after receiving pemetrexed disodium

- No NSAIDS with a long half-life (e.g., naproxen, piroxicam, diflunisal, or
nabumetone) 5 days before, during, and for 2 days after receiving pemetrexed

- Concurrent hormone replacement therapy is permitted

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

- Concurrent use of acetylsalicylic acid (up to 1.3 g/day) allowed

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Safety Issue:


Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center



Study ID:




Start Date:

September 2008

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



MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Carilion Gynecologic Oncology Associates Roanoke, Virginia  24014
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
Cancer Care Associates - Saint Francis Campus Tulsa, Oklahoma  74136-1929
Parkland Memorial Hospital Dallas, Texas  75235
Northeast Georgia Medical Center Gainesville, Georgia  30501
Women's Cancer Center - La Canada Las Vegas, Nevada  89169
Lyndon B. Johnson General Hospital Houston, Texas  77026-1967