Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

NCT00513786 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: OSU-06133NCI-2012-01229
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of this study is to determine the effectiveness of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.

Conditions

Endometrial Cancer

Keywords

Endometrial Cancer; Advanced Stage Endometrial Cancer; Stage 3 or 4 endometrial cancer; Cancer treatment; gyn cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate Patients With Progression Free Survival (PFS)

  Progressive Disease (PD) is defined at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions.

  up to 57 months

Secondary Outcomes (3)

• To Estimate Overall Survival

  up to 24 months

• Number of Patients With Adverse Events as a Measure of Safety and Tolerability.

  up to 24 months

• Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria

  Up to 24 months

Study Arms (1)

carboplatin/paclitaxel with bevacizumab

EXPERIMENTAL

A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.

Drug: Carboplatin; Drug: Paclitaxel; Drug: bevacizumab

Interventions

Carboplatin DRUG

AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.

Also known as: Paraplatin, CBDCA

carboplatin/paclitaxel with bevacizumab

Paclitaxel DRUG

175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.

Also known as: Onxol, Taxol

carboplatin/paclitaxel with bevacizumab

bevacizumab DRUG

15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.

Also known as: Avastin

carboplatin/paclitaxel with bevacizumab

Eligibility Criteria

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

You may qualify if:

• Advanced Stage Endometrial Cancer (Stage 3 or 4)
• Any Histology including clear cell, and serous papillary carcinomas
• surgery must have had hysterectomy and bilateral salpingo-oophorectomy
• chemotherapy initiated 12 weeks after surgery
• sign informed consent
• Adequate End-organ function
• GOG (Gynecologic Oncology Group)Performance Status 0,1,2
• Patients must be 18 years or older
• Patients may have received radiation for the treatment of endometrial cancer.
• Patients may have measurable or non-measurable disease.

You may not qualify if:

• Patient with concomitant malignancy other than non-melanoma skin cancer
• Patients with prior malignancy who have been disease free for 5 years.
• Patients with serious uncontrolled infection, angina or serious peripheral neuropathy.
• Patients whose circumstances will not permit study completion or adequate follow up
• Patients who have received prior cytotoxic chemotherapy for treatment of endometrial cancer including chemotherapy used for radiation sensitization.

Sponsors & Collaborators

• David O'Malley: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The Ohio State University-Division of Gyn Oncology

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Carboplatin; Paclitaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. David O'Malley
• Organization: The Ohio State University Comprehensive Cancer Center

David.O'Malley@osumc.edu

614-293-3873

Study Officials

• David O'Malley, MD

  The Ohio State University Division of Gyn Oncology

  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 INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: August 1, 2007
• Primary Completion: January 3, 2017
• Study Completion: January 3, 2017
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)