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Completed

NCT Number: NCT00190983

A Trial for Patients With Advanced/Recurrent Cervical Cancer

This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Gynecologic Oncology Group 215-854-0770

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed

Drug

Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression.

Primary outcomes

  1. Tumor Response

    Time frame: baseline to measured progressive disease (up to 5 years)

    Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Secondary outcomes

  1. Duration of Response

    Time frame: time of initial response until documented tumor progression (up to 5 years)

    The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

  2. Progression-Free Survival

    Time frame: baseline until documented tumor progression (up to 5 years)

    The period from study entry until disease progression, death or date of last contact.

  3. Overall Survival

    Time frame: baseline until death from any cause (up to 5 years)

    Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Gynecologic Oncology Group

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Nov 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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