Abraxane Plus Carboplatin for Recurrent Platinum-Sensitive Ovarian Cancer

NCT00466986 | Completed Phase 2

• 1 other identifier: WIRB#20051730
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the combination of Abraxane and Carboplatin together will improve the chances of controlling recurrent ovarian/fallopian tube/peritoneal cancer.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Keywords

recurrent; ovarian; cancer; platinum sensitive

Outcome Measures

Primary Outcomes (1)

• Response Rate

  5 years

Secondary Outcomes (6)

• Time to Response

  5 years

• Duration of Response

  5 years

• Overall Survival

  5 years

• Progression Free Survival

  5 years

• Safety

  5 years

Interventions

Abraxane DRUG

Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed recurrent epithelial ovarian or primary peritoneal carcinoma. Patient will have been staged at diagnosis according to FIGO Classification.
• Measurable Disease by RECIST Criteria (defined by the presence of at least 1 measurable lesion (see Section 7.7.1 for definition of measurable lesions) or elevated CA-125 in the absence of measurable disease. A pre-treatment sample of CA-125 will be collected within 2 weeks before treatment is started. A pre-treatment sample of CA-125 should be at least twice the upper limit of normal.
• Patients must have disease recurrence 6 months or more after completion of front-line platinum and paclitaxel-containing regimen. Duration of response from prior therapy and prior consolidation therapy will be documented in case report forms for descriptive analysis.
• Patients must have received at least 3 cycles of a front-line taxane and platinum-containing regimen prior to entry on this study.
• Patients must have a documented complete clinical response on front-line therapy.
• Patients must be disease-free from prior malignancies for more than 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• Life expectancy of \> 6 months.
• ECOG (Zubrod) performance status 0-2.
• Age \>18 years.
• Patient has the following blood counts at Baseline:
• ANC \> 1.5 x 10-9 c/L;
• platelets \> 100 x 10-9 c/L;
• Hgb \> 9 g/dL.
• Patient has the following blood chemistry levels at Baseline:
• AST (SGOT), ALT (SGPT) \< 1.5x upper limit of normal range (ULN);

You may not qualify if:

• Patients who have received more than one prior chemotherapy regimen.
• Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable off therapy for at least 1 month.
• Patient has pre-existing peripheral neuropathy of grade \>/= 2 (per National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events version 3.0 \[CTCAE\].
• Patients receiving concurrent or intervening other chemotherapy, hormonal (for treatment of ovarian carcinoma), immunotherapy, or radiotherapy.
• Patient has a clinically significant concurrent illness.
• Patient is, in the Investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
• Patient has a history of allergy or hypersensitivity to the study drug.
• Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
• Patient is enrolled in any other clinical protocol or investigational trial.
• Patients of childbearing potential, not practicing adequate contraception.

Sponsors & Collaborators

• Southeastern Gynecologic Oncology: lead
• Celgene Corporation: collaborator

Study Sites (1)

Southeastern Gynecologic Oncology

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Recurrence; Neoplasms

Interventions

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Benidict B Benigno, MD

  Southeastern Gynecologic Oncology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 27, 2007
• Study Start: November 1, 2005
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

US (1)