A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas

A Phase II Study of Pemetrexed in Recurrent Cervical Adenocarcinomas

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

Study Overview

• Status: Terminated
• Conditions: Adenocarcinoma of the Cervix; Adenosquamous Cell Carcinoma of the Cervix
• Intervention / Treatment: Drug: Pemetrexed

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Western Regional Medical Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Alimta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate	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 years
Overall Survival	Evaluate Overall survival for recurrent cervical adenocarcinomas treated with pemetrexed.	2 years

Collaborators and Investigators

• Sponsor: Western Regional Medical Center
• Investigators: Principal Investigator: John Farley, MD, Western Regional Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (ESTIMATE): August 16, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Complex and Mixed; Adenocarcinoma; Carcinoma, Adenosquamous; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: CWG2014034 Pemetrexed Cervica

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to present data as abstract format