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A Trial for Patients With Advanced/Recurrent Cervical Cancer

NCT00190983CompletedPHASE2INTERVENTIONAL

Summary

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.

Key Facts

Lead Sponsor

Eli Lilly and Company

Enrollment

Start Date

2005-02-01

Completion Date

2007-10-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Pemetrexed

Conditions

Cervical Intraepithelial NeoplasiaUterine NeoplasmsGenital NeoplasmsFemale

Eligibility

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Tumor Response

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.

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

Secondary Outcomes

Duration of Response

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.

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

Progression-Free Survival

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

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

Overall Survival

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

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

Locations

Gynecologic Oncology Group 215-854-0770, Philadelphia, United States

Linked Diseases

Uterine Neoplasms

Uterine Neoplasms — a type of gynecological cancer.