Full Text View
Tabular View
No Study Results Posted
Related Studies
Abraxane Plus Carboplatin for Recurrent Platinum-Sensitive Ovarian Cancer
This study has been completed.

First Received on April 26, 2007.   Last Updated on October 7, 2011   History of Changes
Sponsor: Southeastern Gynecologic Oncology
Collaborator: Celgene Corporation
Information provided by (Responsible Party): Southeastern Gynecologic Oncology
ClinicalTrials.gov Identifier: NCT00466986
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Drug: Abraxane
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Non-Randomized Study of Abraxane Plus Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by Southeastern Gynecologic Oncology:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Tolerability [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2005
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Abraxane
    Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days
Detailed Description:

Current best practice recommends Carboplatin combined with Taxol in the treatment of Ovarian cancer.

Taxol is paclitaxel in the solvent Cremophor-El and the solvent has been associated with significant side effects e.g. anaphylaxis and hypersensitivity. this requires the routine use of premedication with antihistamines and steroids.

Abraxane by contrast is Cremophor-El free and is protein bound. This has 2 advantages over Taxol.

  1. No need for routine premedications
  2. Increased drug entry into cells facilitating greater potential for anti-tumor activity.

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed recurrent epithelial ovarian or primary peritoneal carcinoma. Patient will have been staged at diagnosis according to FIGO Classification.
  2. 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.
  3. 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.
  4. Patients must have received at least 3 cycles of a front-line taxane and platinum-containing regimen prior to entry on this study.
  5. Patients must have a documented complete clinical response on front-line therapy.
  6. 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.
  7. Life expectancy of > 6 months.
  8. ECOG (Zubrod) performance status 0-2.
  9. Age >18 years.
  10. 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.
  11. Patient has the following blood chemistry levels at Baseline:

    • AST (SGOT), ALT (SGPT) < 1.5x upper limit of normal range (ULN);
    • total bilirubin NORMAL;
    • alkaline phosphatase < 2.5x ULN
    • creatinine < 1.5 mg/dL.
  12. Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.

Exclusion Criteria:

  1. Patients who have received more than one prior chemotherapy regimen.
  2. 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.
  3. Patient has pre-existing peripheral neuropathy of grade >/= 2 (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 3.0 [CTCAE].
  4. Patients receiving concurrent or intervening other chemotherapy, hormonal (for treatment of ovarian carcinoma), immunotherapy, or radiotherapy.
  5. Patient has a clinically significant concurrent illness.
  6. Patient is, in the Investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
  7. Patient has a history of allergy or hypersensitivity to the study drug.
  8. 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.
  9. Patient is enrolled in any other clinical protocol or investigational trial.
  10. Patients of childbearing potential, not practicing adequate contraception.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466986

Locations
United States, Georgia
Southeastern Gynecologic Oncology
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Southeastern Gynecologic Oncology
Celgene Corporation
Investigators
Principal Investigator: Benidict B Benigno, MD Southeastern Gynecologic Oncology
  More Information

No publications provided

Responsible Party: Southeastern Gynecologic Oncology
ClinicalTrials.gov Identifier: NCT00466986     History of Changes
Other Study ID Numbers: WIRB#20051730
Study First Received: April 26, 2007
Last Updated: October 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Southeastern Gynecologic Oncology:
recurrent
ovarian
cancer
platinum sensitive

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012