Phase II Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian and Primary Peritoneal Carcinoma

Washington University School of Medicine1 site in 1 country38 target enrollmentMay 2008

ConditionsOvarian Carcinoma Primary Peritoneal Carcinoma

InterventionsPemetrexed Bevacizumab

DrugsPemetrexed Bevacizumab

Overview

Phase: Phase 2
Intervention: Pemetrexed
Conditions: Ovarian Carcinoma
Sponsor: Washington University School of Medicine
Enrollment: 38
Locations: 1
Primary Endpoint: Progression-free Survival (PFS)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if the combination of bevacizumab and pemetrexed have an effect on recurrent ovarian and primary peritoneal carcinoma by looking at progression and survival at 6 months.

Detailed Description

Patients will be treated with pemetrexed 500 mg/m2 IV and Bevacizumab 15 mg/kg IV every 3 weeks.The patient is treated indefinitely until side effects are deemed severe by the investigator or until progression. Disease progression is measured every 6 weeks using RECIST criteria.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

December 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Recurrent epithelial ovarian or primary peritoneal carcinoma. Histologic confirmation of the primary tumor is required. Patients with borderline tumors are not eligible.
•Patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in one dimension (longest dimension to be recorded). Each lesion must by \> 20 mm when measured by conventional imaging techniques, including plain radiography, computed tomography and MRI or \> 10 mm when measured by spiral CT.
•Patients must have at least one "target lesion" to assess response by RECIST criteria. Lesions within a previously irradiated field will be considered "non-target" lesions.
•Patients must have a GOG performance status of 0 or
•Patients must have the ability to interrupt non-steroidal anti-inflammatory (NSAID) treatment 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
•Patients must have the ability to take folic acid, vitamin B12 and dexamethasone as described per protocol.
•Recovery from effects of recent surgery, radiotherapy or chemotherapy.
•Patients should be free of active infection requiring antibiotics.
•Any hormonal therapy directed at the tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy (HRT) is permitted.
•Any other prior therapy directed at the malignant tumor, including immunologic agents and cytotoxic agents, must be discontinued at least three weeks prior to registration.

Exclusion Criteria

•Patients with serious, non-healing wound, ulcer or bone fracture.
•Patients with clinically significant cardiovascular disease:
•Inadequately controlled hypertension (defined as systolic blood pressure \> 150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
•Any prior history of hypertensive crisis or hypertensive encephalopathy.
•Unstable angina within 6 months prior to study enrollment.
•New York Heart Association (NYHA) grade II or greater congestive heart failure.
•Serious cardiac arrhythmia requiring medication.
•Grade II or greater peripheral vascular disease. Patients with claudication within 6 months.
•History of myocardial infarction within 6 months.
•Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.

Arms & Interventions

Pemetrexed and bevacizumab

Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle

Intervention: Pemetrexed

Pemetrexed and bevacizumab

Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle

Intervention: Bevacizumab

Outcomes

Primary Outcomes

Progression-free Survival (PFS)

Time Frame: 6 months

PFS = Period from study entry until disease progression, death, or date of last contact

Secondary Outcomes

Distribution of Progression-free Survival (PFS)(Median follow-up was 25.7 months (range 3.0-47.2 months))
Toxicity Associated With Bevacizumab and Pemetrexed(6 months)
Distribution of Overall Survival (OS)(Median follow-up was 25.7 months (range 3.0-47.2 months))
Frequency of Clinical Response(6 months)
Gene Expression as Assessed by Illumina cDNA Mediated Annealing, Selection, Extension and Ligation (DASL) Microarray From Paraffin-embedded Tumor Specimens With Response to Pemetrexed and Bevacizumab(6 months)
Association Between Levels of Thymidylate Synthase, Dihydrofolate Reductase, and Glycinamide Ribonucleotide Formyl Transferase and Ovarian Response to Pemetrexed and Bevacizumab(6 months)