Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary Peritoneal Carcinoma

NCT00868192 | Completed Phase 2 Results DMC

• 1 other identifier: 08-0508 / 201102272
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Carcinoma; Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

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

  6 months

Secondary Outcomes (6)

• Distribution of Progression-free Survival (PFS)

  Median follow-up was 25.7 months (range 3.0-47.2 months)

• Distribution of Overall Survival (OS)

  Median follow-up was 25.7 months (range 3.0-47.2 months)

• Toxicity Associated With Bevacizumab and Pemetrexed

  6 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

Study Arms (1)

Pemetrexed and bevacizumab

EXPERIMENTAL

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

Drug: Pemetrexed; Drug: Bevacizumab

Interventions

Pemetrexed DRUG

Also known as: Alimta

Pemetrexed and bevacizumab

Bevacizumab DRUG

Also known as: Avastin

Pemetrexed and bevacizumab

Eligibility Criteria

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

You may qualify if:

• 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 1.
• 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.
• Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment.
• Patients must have had one prior regimen containing a taxane compound. Patient may have received first-line treatment either intravenously or intraperitoneally.
• Patients must NOT have received prior therapy with pemetrexed or bevacizumab.
• Patients may have received a total of \< 2 prior cytotoxic chemotherapy regimens (adjuvant therapy plus one additional regimen). Consolidation or extended therapy as part of first line treatment will be considered as a single regimen.
• Bone marrow function: absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria (CTC) grade 1; Platelets greater than or equal to 100,000/ul.

You may not qualify if:

• 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.
• Patients with the presence of ascites or other third space fluid which cannot be controlled by drainage.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of study or anticipation of need for major surgical procedure during the course of the study.
• Patients with history or evidence upon physical examination of central nervous system disease, including primary brain tumor, brain metastases, seizure not controlled with standard medical therapy, history of cerebrovascular accident (CVA, stroke), or transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study.
• Minor surgical procedures, other than central venous access placement, such as fine needle aspiration or core biopsy within 7 days prior to day 1 of study.
• Patients with proteinuria. At baseline patients will undergo a urine protein-creatinine ratio (UPCR) (Appendix IV). Patients with a UPCR \> 1.0 at screening should be excluded. Urine dipstick for proteinuria may also be used. Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Columbia University: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

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Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Pemetrexed; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

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; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: David G. Mutch, M.D.
• Organization: Washington University School of Medicine

mutchd@wudosis.wustl.edu

314-362-2181

Study Officials

• David G Mutch, M.D.

  Washington University School of Medicine

  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: March 18, 2009
• First Posted: March 24, 2009
• Study Start: May 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 20, 2014
• Results First Posted: October 20, 2014

Record last verified: 2014-10

Locations

US (1)