Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Bevacizumab

Pemetrexed

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

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

David G Mutch, M.D.

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.

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.

Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary Peritoneal Carcinoma

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

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

OS = observed length of time from entry into the study to death or date of last contact

Detailed serious adverse events and other adverse events are shown in the adverse event module of the results.

Columbia University

Washington University School of Medicine

Pemetrexed and Bevacizumab

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Stage I/II

Stage III

Stage IV

Staging

* I:The cancer is only within the ovary(ies) or fallopian tube(s)
* II:Cancer involves 1 or both ovaries or fallopian tube(s) with pelvic extension
* III: Cancer involves 1 or both ovaries or fallopian tubes(s) with microscopically confirmed peritoneal metastases outside the pelvis and/or regional lymph node metastasis (also can be primary peritoneal cancer)
* IV:Distant spreading (also can be primary peritoneal cancer)

Stage

Serous

Endometriod

Mixed

Other

Histology

Grade 1

Grade 2

Grade 3

G1: The tissue is well-differentiated (contains many healthy-looking cells).

G2: The tissue is moderately differentiated (more cells appear abnormal than healthy).

G3:The tissue is poorly differentiated or undifferentiated (all or most cells appear abnormal).

Tumor grade

Ovarian

Fallopian tube

Primary peritoneal

Pathologic diagnosis

GOG Performance Status

* 0 = Fully active, unrestricted activities of daily living
* 1 = Ambulatory, but restricted in strenuous activity

Gynecologic Oncology Group (GOG) Performance Status

Prior number of chemotherapy regimens

<6 months

6-12 months

>12 months

Platinum-free interval

David G. Mutch, M.D.

Progression-free Survival (PFS)

Platinum-free interval of <6 months

Platinum-free interval of 6-12 months

Platinum-free interval of >12 months

Distribution of Progression-free Survival (PFS)

Distribution of Overall Survival (OS)

Grade 3/4 hematologic toxicity

Most common non-hematologic toxicity - fatigue

Grade 3 renal toxicity

Gastrointestinal toxicity

Subsequently developed hematologic malignancies

Toxicity Associated With Bevacizumab and Pemetrexed

Complete response

Partial response

Stable disease

Progressive disease

Frequency of Clinical Response

This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.

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

Association Between Levels of Thymidylate Synthase, Dihydrofolate Reductase, and Glycinamide Ribonucleotide Formyl Transferase and Ovarian Response to Pemetrexed and Bevacizumab

Overall Survival (OS)

Overall response rate = complete response + partial response

Complete response = disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.

Partial response = at least a 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be non unequivocal progression of non-target lesions and no new lesions.

Overall Response Rate

50% CA-125 response

75% CA-125 response

No CA-125 response

A CA-125 response was defined as at least a 50% reduction in CA-125 levels from a pretreatment sample following guidelines described by the Gynecological Cancer Intergroup.

7 participants were not evauable by CA-125 criteria.

CA-125 Response

Overall Study

Spots Global Cancer Trial Database for Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary Peritoneal Carcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial