A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

NCT00698451 | Completed Phase 2 Results

• 2 other identifiers: CR015094DOXILOVC2007
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten 28-day cycles. Patients will be followed for six months following treatment to assess progression-free survival.

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms

Keywords

Ovarian cancer; fallopian tube cancer; primary peritoneal cancer; DOXIL; carboplatin; bevacizumab

Outcome Measures

Primary Outcomes (1)

• The Primary Efficacy End Point is the Number of Patients With an Objective Response.

  Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD

  Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)

Secondary Outcomes (1)

• The Secondary Efficacy Endpoints is Duration of Objective Response.

  Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.

Study Arms (1)

001

EXPERIMENTAL

doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle

Drug: doxorubicin HCL liposome; bevacizumab; carboplatin

Interventions

doxorubicin HCL liposome; bevacizumab; carboplatin DRUG

30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle

001

Eligibility Criteria

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

You may qualify if:

• Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer
• Relapse-free interval of \>6 months afer completion of first line platinum-based chemotherapy
• Measurable disease (at least one lesion that can be accurately measured in a least 1 dimension)
• Adequate bone marrow function, renal, and liver function. Normal cardiac function
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

You may not qualify if:

• No patients who have received more than 1 previous regimen of chemotherapy (maintenance is not considered a second regimen)
• No patients receiving immunotherapy or radiotherapy or patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis
• No patients who require parenteral hydration or nutrition or have clinical signs or symptoms of gastrointestinal bowel obstruction or perforation
• No patients with previous or current malignancy other than basal cell or squamous cell carcinoma of the skin
• No patients with clinically significant cardiovascular disease
• No patients with a history of bevacizumab or other VEGF or VEGF receptor-targeted agent use.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Centocor Ortho Biotech Services, L.L.C.: collaborator

Study Sites (1)

Unknown Facility

Horsham, Pennsylvania, 19044, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms

Interventions

Bevacizumab; Carboplatin

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; Fallopian Tube Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

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

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Services, LLC

tmcgowan@its.jnj.com

1 215 325-5329

Study Officials

• Tracey McGowan, MD

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 17, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 6, 2013
• Results First Posted: July 12, 2013

Record last verified: 2013-08

Locations

US (1)