Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian

NCT01219777 | Completed Phase 1 Results DMC

• 2 other identifiers: OSU-09149NCI-2012-00512
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo surgery which will allow an objective measure of response to the above regimen as well as assessment of surgical outcomes.

Conditions

Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Keywords

bevacizumab; paclitaxel; carboplatin; ovarian; cancer; fallopian tube; primary peritoneal

Outcome Measures

Primary Outcomes (1)

• Tolerated Dose

  To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.

  Up to 6 months

Secondary Outcomes (1)

• Toxicity and Response Rates Based on Imaging and Surgical Outcomes

  Up to 6 months

Study Arms (3)

Carboplatin

EXPERIMENTAL

AUC 5.0 or 6.0

Drug: carboplatin

Bevacizumab

EXPERIMENTAL

15 mg/kg

Drug: Bevacizumab

Paclitaxel

EXPERIMENTAL

60-80 mg/m2

Drug: Paclitaxel

Interventions

carboplatin DRUG

Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.

Also known as: Paraplatin®, CBDCA

Carboplatin

Bevacizumab DRUG

Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.

Also known as: Avastin

Bevacizumab

Paclitaxel DRUG

60-80 mg/m2 administered on Day 1, 8 \& 15 during cycle 1-3. Treatment cycle consists of 21 days duration.

Also known as: Taxol, Abraxane

Paclitaxel

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histology,cytologically diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer
• FIGO (International Federation of Gynecology and Obstetrics stage III or IV disease
• GOG (Gynecologic Oncology Group) Performance Status 0,1,2
• No prior surgery for their malignancy
• Adequate bone marrow function
• Platelet count greater than or equal to 100,000
• Renal Function: Creatinine \< 1.5 institutional upper limit normal
• Hepatic Function: Bilirubin less than 1.5 ULN (upper limit of normal)
• Hepatic Function: SGOT (serum glutamate oxaloacetate transaminase) and Alkaline Phosphate
• Neurologic Function: Neuropathy less than CTCAE (Common Toxicity Criteria for Adverse Effects)grade 1
• Coagulation Functions: INR\<1.5 and PTT ,1.2 times the upper limit of normal
• Measurable disease

You may not qualify if:

• Previous cancer related surgery
• Received prior chemotherapy, immunotherapy, radiotherapy, hormonal therapy or biologic therapy for their ovarian, fallopian tube or primary peritoneal cancer.
• Borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer or non-epithelial ovarian are not eligible.
• Other cancers within 5 years (other than non-melanoma skin cancer)
• Acute Hepatitis or end stage liver disease
• History of prior gastrointestinal perforation
• Evidence of abdominal free air not explained by paracentesis
• Sign or symptoms of gastrointestinal obstruction
• Active bleeding or pathologic conditions that carry high risk of bleeding
• CNS (Central Nervous System) disease
• Clinically Significant cardiovascular disease
• Known hypersensitivity to Chinese Hamster ovary cell products or other recombinant human or humanized antibodies
• Clinically significant proteinuria.
• Hypertensive crises or hypertensive encephalopathy
• History of hemoptysis

Sponsors & Collaborators

• Ritu Salani: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Neoplasms

Interventions

Carboplatin; Bevacizumab; Paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; 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; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ritu Salani, MD, MBA
• Organization: The Ohio State University Comprehensive Cancer Center

Ritu.Salani@osumc.edu

614-293-3873

Study Officials

• Ritu Salani, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 13, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2015
• Last Updated: February 8, 2018
• Results First Posted: June 29, 2015

Record last verified: 2015-05

Locations

US (1)