Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression

NCT00659399 | Withdrawn Phase 1 DMC

• 1 other identifier: 07-742
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess feasibility and safety of using once daily Fondaparinux Sodium (ARIXTRA®) in patients with ovarian cancer who are in 'clinical remission' (no clinical evidence of disease) after chemotherapy but at high risk of ovarian cancer recurrence.

Conditions

Ovarian Carcinoma

Keywords

Pretreated Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• Estimate the proportion of patients who complete an eight week course of once daily administration of fondaparinux (Arixtra).

  15 months

Secondary Outcomes (1)

• Time to Recurrence

  24 months

Interventions

Fondaparinux DRUG

Arixtra 2.5 mg by subcutaneous injection once daily for 8 weeks or until disease recurrence or grade 3, 4 adverse events.

Also known as: Arixtra, fondaparinux sodium

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age and ≤75 years of age
• Biopsy-proven ovarian, tubal or primary peritoneal epithelial adenocarcinomas;
• Performance status 0,1 (ECOG) ( table 2)
• Patients at high risk of clinical relapse: first remission stage III/IV who were suboptimally debulked (residual disease \>1 cm)
• Patients of any stage who have recurred and are in second chemotherapy induced remission. Clinical remission defined as:
• absence of symptoms that may be related to disease
• imaging without abnormalities greater then or equal to 1 cm suspicious for disease (no ascites)
• CA 125 obtained x 1 and \<35 units/ml.
• Adequate end organ function, defined as the following:
• Total bilirubin \< 1.5 x ULN
• SGOT and SGPT \< 2.5 x UNL
• Creatinine \< 1.5 x ULN
• ANC \> 1.5 x 109/L
• Platelets \> 100 x 109/L
• Weight ≥ 50 kg

You may not qualify if:

• Patients with performance status ECOG =2,3,4
• Patients who are on warfarin or prior therapeutic anticoagulation
• Patient has another primary malignancy that has required active intervention within 5 years, with the exception of basal cell skin cancer or a cervical carcinoma in situ.
• Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
• Patient who had a major surgery within 2 weeks prior to study entry
• Patients with the following lab abnormalities:
• WBC \<3000
• absolute neutrophil count \< 1,500
• hemoglobin \<10 g/dL
• platelet \< 100,000
• creatinine clearance \<30 cc/min
• serum ALT, AST, or total bilirubin \>1.5X the upper limit of normal
• Patients with known bleeding disorder

Sponsors & Collaborators

• NYU Langone Health: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

NYU Cancer Institute Clinical Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Fondaparinux

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)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Boris Kobrinsky, M.D.

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 16, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

US (1)