Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients

NCT00583622 | Terminated Phase 2 Results

• 1 other identifier: 2007-0368
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if bevacizumab, when given in combination with gemcitabine, docetaxel, melphalan and carboplatin, or with topotecan, cyclophosphamide and melphalan (if you are older than 60 or have an allergy to carboplatin), can help to control ovarian cancer during a stem cell transplant. The safety of this drug combination will also be studied.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Epithelial Ovarian Cancer; Bevacizumab; Carboplatin; Gemcitabine; Docetaxel; Melphalan

Outcome Measures

Primary Outcomes (1)

• Event-Free (EF) Rate

  Percent of participants free of relapse or disease progression at end of 6 months. Event-free survival estimated from the first day of High-dose chemotherapy (day-6) until tumor progression, relapse, or death from any cause.

  Up to 6 Months

Secondary Outcomes (1)

• Participant Response

  Up to 6 months

Study Arms (1)

Bevacizumab + High-Dose Chemotherapy

EXPERIMENTAL

Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m\^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m\^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m\^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant

Drug: Bevacizumab; Drug: Carboplatin; Drug: Docetaxel; Drug: Gemcitabine; Drug: Melphalan; Procedure: Stem Cell Transplant

Interventions

Bevacizumab DRUG

5 mg/kg by vein daily over 90 minutes for 2 Days

Also known as: Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

Bevacizumab + High-Dose Chemotherapy

Carboplatin DRUG

333 mg/m\^2 by vein over 2 hours for 3 Days

Also known as: Paraplatin®

Bevacizumab + High-Dose Chemotherapy

Docetaxel DRUG

300 mg/m\^2 by vein over 2 hours for 1 Day

Also known as: Taxotere

Bevacizumab + High-Dose Chemotherapy

Gemcitabine DRUG

1,800 mg/m2 by vein over 3 hours for 4 Days

Also known as: Gemzar®, Gemcitabine Hyrdrochloride

Bevacizumab + High-Dose Chemotherapy

Melphalan DRUG

50 mg/m\^2 by vein over 15 minutes for 3 Days

Bevacizumab + High-Dose Chemotherapy

Stem Cell Transplant PROCEDURE

* Stem Cell Removal via apheresis through a central venous catheter (CVC), usually in chest * Stem Cell Replacement through CVC over about 30-60 minutes, Day 7 of treatment, following study drug regimen

Also known as: SCT

Bevacizumab + High-Dose Chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - \<70.
• Patients with advanced ovarian, fallopian or primary peritoneal cancer in second or later complete remission, or untreated or refractory relapse, defined as relapse within 6 months of prior platinum treatment or lack of response to salvage treatment.
• No evidence of small bowel obstruction, as determined by CT scan of the abdomen and pelvis with oral and rectal contrast, within 30 days before the initiation of study treatment.
• Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance \>=60 ml/min, and urinary protein excretion \<=500 mg/day.
• Adequate hepatic function, as defined by serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) \<=3 \* upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \<=2 \* ULN or considered not clinically significant.
• Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) \>=50% of predicted, corrected for volume or hemoglobin.
• Adequate cardiac function with left ventricular ejection fraction \>=45%. No uncontrolled arrhythmias or symptomatic cardiac disease.
• Zubrod performance status \<2.

You may not qualify if:

• Failure to collect more than 3 \* 10e6 CD34+ stem cells/kg body weight
• Patients with unresolved grade 3 or greater non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the principal investigator.
• Major surgery within 30 days before the initiation of study treatment
• Radiotherapy within 21 days prior to initiation of study treatment
• Patients with active Central Nervous System (CNS) disease.
• Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Principal Investigator and consider liver biopsy.
• Uncontrolled infection, including HIV or HTLV-1 infection.
• Aspirin (\> 325 mg/day) use within 10 days before initiation of study treatment.
• Ongoing uncontrolled hypertension (\>140/90 mm Hg on medication).
• Non-healing wound or significant traumatic injury within 30 days before the initiation of study treatment
• Previous autologous or allogeneic stem cell transplant during the past year.
• Positive Beta HCG test in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center website

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Bevacizumab; Carboplatin; Docetaxel; Gemcitabine; Melphalan; Stem Cell Transplantation

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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Yago Nieto, MD, PhD / Professor
• Organization: The University of Texas MD Anderson Cancer

celsaenz@mdanderson.org

Study Officials

• Yago Nieto, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: December 20, 2007
• First Posted: December 31, 2007
• Study Start: December 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 21, 2013
• Results First Posted: May 21, 2013

Record last verified: 2013-04

Locations

US (1)