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A Phase II Evaluation of Pemetrexed (Alimta) in the Treatment of Recurrent Carcinoma of the Cervix


Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Intraepithelial Neoplasia, Uterine Neoplasms, Genital Neoplasms, Female

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Trial Information

A Phase II Evaluation of Pemetrexed (Alimta) in the Treatment of Recurrent Carcinoma of the Cervix


Inclusion Criteria:



- Recurrent squamous or non-squamous cell carcinoma of the cervix with documented
disease progression

- Measurable disease

- Gynecologic Oncology Group (GOG) performance status 0-2

- Patients must have received one prior systemic chemotherapy for persistent or
recurrent disease

- Patients with mild to moderate renal insufficiency should avoid taking non-steroidal
anti-inflammatory drugs (NSAIDs_ with short elimination half-lives for a period of 2
days before, the day of, and 2 days following administration of pemetrexed.

- All patients taking NSAIDs with longer half-lives, should interrupt dosing for at
least 5 days before, the day of, and 2 days following pemetrexed administration.

- Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior
to first does of pemetrexed and continuing daily until 3 weeks after the last dose of
study therapy.

- Vitamin B12 (1000 ug) will be administered as an intramuscular injection
approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated
approximately every 9 weeks until 3 weeks after the last dose of study therapy

Exclusion Criteria:

- Prior Pemetrexed

- Patients who have received radiation to more than 25% of marrow bearing areas

- Any evidence of other malignancy within last 5 years, with exception of non-melanoma
skin cancer

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tumor Response

Outcome Time Frame:

baseline to measured progressive disease (up to 5 years)

Safety Issue:

No

Principal Investigator

David Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

8367

NCT ID:

NCT00190983

Start Date:

February 2005

Completion Date:

October 2007

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Uterine Neoplasms
  • Genital Neoplasms, Female
  • Neoplasms
  • Genital Neoplasms, Female
  • Uterine Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location

Gynecologic Oncology Group 215-854-0770Philadelphia, Pennsylvania