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Ovarian CancerPhase 2NCT00466986

Abraxane Plus Carboplatin for Recurrent Platinum-Sensitive Ovarian Cancer

A Phase 2 study testing Abraxane in people with Ovarian Cancer and Fallopian Tube Cancer, run by Southeastern Gynecologic Oncology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Abraxane
How many people
40 participants
Where
1 siteUnited States
Study dates
Nov 2005to Oct 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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);
  • total bilirubin NORMAL;
  • alkaline phosphatase < 2.5x ULN
  • creatinine < 1.5 mg/dL.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Southeastern Gynecologic Oncology

    Atlanta, Georgia, 30342

Other trials in United States

About this study

Official title: A Phase II, Non-Randomized Study of Abraxane Plus Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

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.

Read the 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.

Being tested
Abraxane
Keywords
recurrent, ovarian, cancer, platinum sensitive
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Recurrence, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbraxaneDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate

    Measured: 5 years

Secondary outcomes (6)

  1. Time to Response

    Measured: 5 years

  2. Duration of Response

    Measured: 5 years

  3. Overall Survival

    Measured: 5 years

  4. Progression Free Survival

    Measured: 5 years

  5. Safety

    Measured: 5 years

  6. Tolerability

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2007 (estimated)
  2. Study startNov 2005
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00466986
Sponsor's protocol ID
WIRB#20051730
Status last verified
Oct 2011
First submitted
26 Apr 2007
Last updated
12 Oct 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abraxane in people with Ovarian Cancer and Fallopian Tube Cancer, run by Southeastern Gynecologic Oncology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00466986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.

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