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A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas

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ClinicalTrials.gov Identifier: NCT02868892
Recruitment Status : Terminated (departure of PI from institution and poor population for study participation)
First Posted : August 16, 2016
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Western Regional Medical Center

Brief Summary:
Patients with advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the cervix will receive Pemetrexed.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Cervix Adenosquamous Cell Carcinoma of the Cervix Drug: Pemetrexed Phase 2

Detailed Description:

Patients will receive Pemetrexed 500 mg/m2 every three week.

On initiation of pemetrexed, on day one of first chemotherapy cycle, patients will begin taking folic acid at a dose of 350 to 600 mcg daily as well as receive an intramuscular injection of 1000 mcg of vitamin B12, with subsequent vitamin B12 injections given every 9 weeks while on study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Pemetrexed in Recurrent Cervical Adenocarcinomas
Study Start Date : July 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pemetrexed
Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle.
Drug: Pemetrexed
Pemetrexed 500 mg/m2
Other Name: Alimta




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]
    Evaluate the progression free survival of recurrent cervical adenocarcinoma. Progression-Free Survival is defined as the period of time from the date of first study drug administration to the date that the subject is determined to have progressive disease or death due to any cause.


Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 2 years ]
    Evaluate the response rate for recurrent cervical adenocarcinomas treated with pemetrexed. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension which must have been 20 mm when measured by conventional techniques including palpation, plain X-ray, CT, and MRI or 10 mm when measured by spiral CT.

  2. Overall Survival [ Time Frame: 2 years ]
    Evaluate Overall survival for recurrent cervical adenocarcinomas treated with pemetrexed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have had advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the cervix with documented disease progression
  2. Patients must have had measurable disease defined as at least one lesion that could be accurately measured in at least one dimension, which must have been 20 mm when measured by conventional techniques including palpation, plain X-ray, computerized tomography (CT), and magnetic resonance imaging(MRI) or 10 mm when measured by spiral CT
  3. 18 years of age or older
  4. Eastern Cooperative Oncology Group (ECOG) performance status score < 2 and a life expectancy >3 months
  5. Life expectancy ≥ 12 weeks
  6. Participants must have measureable disease by RECIST criteria
  7. Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
  8. Creatinine clearance ≥ 45 mL/min using the standard Cockcroft and Gault formula (below) or glomerular filtration rate (GFR) measured by Tc99m-diethylenetriaminepentacetate (DPTA) serum clearance method:

    1. Males: [140 - Age in years] × Actual Body Weight (kg) 72 × Serum Creatinine (mg/dL)
    2. Females: Estimated creatinine clearance for males × 0.85
  9. Total bilirubin ≤ 2 mg/dL, aspartate transaminase (AST) and alanine transaminase (ALT) AST/ALT ≤ 5 times the upper limit of normal range
  10. At least 21 days from administration of chemotherapy
  11. No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
  12. At least four (4) weeks from prior major surgery
  13. Willingness to provide permission to access archived tumor samples and additional blood samples for evaluation of Foundation One Analysis where available Enterprise wide.
  14. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.

Exclusion Criteria:

  1. Uncontrolled cardiac disease, congestive heart failure, angina, arrhythmias or hypertension.
  2. Myocardial infarction or unstable angina within 2 months of treatment.
  3. Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol).
  4. Active clinically serious infection > CTCAE (version 4.03) Grade 2.
  5. Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  6. Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug.
  7. Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug.
  8. Serious non-healing wound, ulcer, or bone fracture.
  9. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
  10. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
  11. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.

Information from the National Library of Medicine

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): NCT02868892


Locations
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United States, Arizona
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Western Regional Medical Center
Investigators
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Principal Investigator: John Farley, MD Western Regional Medical Center
  Study Documents (Full-Text)

Documents provided by Western Regional Medical Center:
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Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT02868892    
Other Study ID Numbers: CWG2014034 Pemetrexed Cervica
First Posted: August 16, 2016    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to present data as abstract format
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma, Adenosquamous
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors