A Trial for Patients With Advanced/Recurrent Cervical Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00190983 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Results First Posted : August 24, 2009
Last Update Posted : November 20, 2009
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Intraepithelial Neoplasia Uterine Neoplasms Genital Neoplasms, Female | Drug: Pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Evaluation of Pemetrexed (Alimta) in the Treatment of Recurrent Carcinoma of the Cervix |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | October 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Pemetrexed |
Drug: Pemetrexed
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression. |
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190983
United States, Pennsylvania | |
Gynecologic Oncology Group 215-854-0770 | |
Philadelphia, Pennsylvania, United States |
Study Chair: | David Miller, MD | Gynecologic Oncology Group |
ClinicalTrials.gov Identifier: | NCT00190983 |
Other Study ID Numbers: |
8367 H3E-US-JMGS |
First Posted: | September 19, 2005 Key Record Dates |
Results First Posted: | August 24, 2009 |
Last Update Posted: | November 20, 2009 |
Last Verified: | November 2009 |
Neoplasms Cervical Intraepithelial Neoplasia Uterine Neoplasms Genital Neoplasms, Female Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urogenital Neoplasms |
Neoplasms by Site Uterine Diseases Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |