A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas

NCT02868892 | Terminated Phase 2 Results DMC

• 1 other identifier: CWG2014034 Pemetrexed Cervica
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adenocarcinoma of the Cervix; Adenosquamous Cell Carcinoma of the Cervix

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Response Rate

  2 years

• Overall Survival

  2 years

Study Arms (1)

Pemetrexed

EXPERIMENTAL

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

Interventions

Pemetrexed DRUG

Pemetrexed 500 mg/m2

Also known as: Alimta

Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have had advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the cervix with documented disease progression
• 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
• years of age or older
• Eastern Cooperative Oncology Group (ECOG) performance status score \< 2 and a life expectancy \>3 months
• Life expectancy ≥ 12 weeks
• Participants must have measureable disease by RECIST criteria
• Absolute neutrophil count \> 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
• 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:
• Males: \[140 - Age in years\] × Actual Body Weight (kg) 72 × Serum Creatinine (mg/dL)
• Females: Estimated creatinine clearance for males × 0.85
• Total bilirubin ≤ 2 mg/dL, aspartate transaminase (AST) and alanine transaminase (ALT) AST/ALT ≤ 5 times the upper limit of normal range
• At least 21 days from administration of chemotherapy
• No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
• At least four (4) weeks from prior major surgery
• Willingness to provide permission to access archived tumor samples and additional blood samples for evaluation of Foundation One Analysis where available Enterprise wide.

You may not qualify if:

• Uncontrolled cardiac disease, congestive heart failure, angina, arrhythmias or hypertension.
• Myocardial infarction or unstable angina within 2 months of treatment.
• 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).
• Active clinically serious infection \> CTCAE (version 4.03) Grade 2.
• Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug.
• Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug.
• Serious non-healing wound, ulcer, or bone fracture.
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
• Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
• Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Western Regional Medical Center, Inc.

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Jessica L. Coats
• Organization: WRMC

jessica.coats@ctca-hope.com

6233417220

Study Officials

• John Farley, MD

  Western Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: August 16, 2016
• Study Start: July 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)