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Fallopian Tube NeoplasmsPhase 1NCT00407407

ABI-007 With Carboplatin as First-Line Therapy in Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

A Phase 1 study testing ABI-007 and Carboplatin in people with Fallopian Tube Neoplasms and Peritoneal Neoplasms, run by Celgene at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary purpose of this study is to determine the maximum tolerated dose and dose-limiting toxicities (DLTs) of weekly and every 3-weeks ABI-007 in combination with carboplatin (area under the curve [AUC]=6) in patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
ABI-007 and Carboplatin
Type of treatment
Injection or infusion
How many people
6 participants
Where
1 siteUnited States
Study dates
1 Nov 2006to 1 Feb 2008
Phase
Phase 1
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a histological diagnosis of primary peritoneal carcinoma, fallopian tube or epithelial ovarian carcinoma (Stage III or IV) with either (optimal less than or equal to 1 cm) residual disease or suboptimal residual disease following initial appropriate surgery.
  • Patients with the following histologically confirmed types of ovarian cancer are eligible: serous cystadenocarcinoma, mucinous cystadenocarcinoma, clear cell adenocarcinoma, adenocarcinoma (unspecified), malignant Brenner's tumor, endometrioid adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma and transitional cell carcinoma. Patients with extraovarian papillary serous cystadenocarcinoma are eligible.
  • Patients who do not have measurable disease may be included and will be assessed for toxicity and progression-free survival only. Measurable disease is NOT required but when present will be followed to assess response. For patients to be evaluated for response of measurable disease, tumor must be greater than or equal to 2.0 cm with conventional computed tomography (CT) imaging or greater than or equal to 1.0 cm with spiral CT imaging.
  • No prior chemotherapy for ovarian cancer is permitted.
  • Patients must be entered no more than 12 weeks postoperatively.
  • ECOG performance status 0-2.
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  • Age greater than or equal to 18 years.
  • Patient has the following blood counts at Baseline:
  • ANC greater than or equal to 1.5 x 10^9 cells/L;
  • Platelets greater than or equal to 100 x 10^9 cells/L;
  • Hemoglobin (Hgb) greater than or equal to 9 g/dL.
  • Patient has the following blood chemistry levels at Baseline:
  • AST (SGOT), ALT (SGPT) less than or equal to 2.5x upper limit of normal range (ULN);
  • Total bilirubin less than or equal to ULN;
  • Creatinine less than or equal to 1.5 mg/dL.
  • Peripheral neuropathy Grade 0 or 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
  • It is assumed that almost all patients already had bilateral oophorectomy. However, if a female of childbearing potential, has a negative pregnancy test (within 72 hours of the first dose of study drug), the patient must agree to use an effective method to avoid pregnancy for the duration of the study.
  • Patients must have signed an approved informed consent and authorization permitting the release of personal health information.

Who cannot join

  • Patients who have received any prior treatment, other than initial debulking surgery, for the cancer being treated in this study. Patients may have received adjuvant chemotherapy for localized breast cancer, if the therapy was completed greater than or equal to 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck or skin is permitted if it was completed greater than or equal to 3 years before registration in this study and if the patient remains free of recurrent metastatic disease.
  • Concurrent immunotherapy or hormonal therapy for ovarian cancer.
  • Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment for the disease.
  • Serious intercurrent medical or psychiatric illness, including serious active infection (i.e. requiring antibiotics).
  • Patients with borderline or low malignant potential tumors.
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  • History of other malignancy within the last 5 years, which could affect the diagnosis or assessment of ovarian cancer.
  • Patients who have received an investigational drug within the previous 3 weeks.
  • Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also, a patient may not enroll in such clinical trials while participating in this study.
  • Pregnant or nursing women.
  • Patients with unstable angina or those who have had myocardial infarction within the past 6 months. Patients with evidence of cardiac conduction abnormalities (e.g., bundle branch block, heart block) are eligible if their cardiac status has been stable for the 6 months prior to study entry.
  • Patients with prior hypersensitivity to both Taxol and Taxotere.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77230-1439

Other trials in United States

About this study

Official title: A Phase I Dose Escalation Study of ABI-007 With Carboplatin TM as First-Line Therapy in Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

The primary purpose of this study is to determine the maximum tolerated dose and dose-limiting toxicities (DLTs) of weekly and every 3-weeks ABI-007 in combination with carboplatin (area under the curve [AUC]=6) in patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Being tested
ABI-007, Carboplatin
Keywords
Epithelial ovarian, Primary peritoneal or fallopian tube carcinoma, Abraxane, Carboplatin
Medical subject headings
Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms

What participants receive

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

  • ABI-007Drug

    80mg/m^2 to 150mg/m^2 IV every 3 weeks

  • CarboplatinDrug

    6 AUC IV every 3 weeks on the same day as ABI-007

What is being measured

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

  1. Primary: Safety/tolerability endpoints are the maximum tolerated dose and dose-limiting toxicities

    Measured: 18 months

Secondary outcomes (1)

  1. Safety-AEs, SAEs, Lab abnormalities, incidence of patients experiencing dose modification of those interruptions &/or premature of d/c pf study drug

    Measured: Patient progression or until discontinuation

Timeline

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

  1. First posted5 Dec 2006 (estimated)
  2. Study start1 Nov 2006
  3. Primary completion1 Feb 2008
  4. Study completion1 Feb 2008

Why it stopped: MTD not determined

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00407407
Sponsor's protocol ID
CA034
Status last verified
Oct 2019
First submitted
1 Dec 2006
Last updated
18 Oct 2019
Results posted
No
Data monitoring committee
No

Publications

  • Hafner C, Windpassinger M, Tretter EV, Rebernig KA, Reindl SM, Hochreiter B, Dekan S, Haider P, Kiss H, Klein KU, Wohlrab P. Role of mitochondrial DNA level in epidural-related maternal fever: a single-centre, observational, pilot study. BMC Pregnancy Childbirth. 2024 May 3;24(1):341. doi: 10.1186/s12884-024-06551-7.

    PubMed 38702618

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABI-007 and Carboplatin in people with Fallopian Tube Neoplasms and Peritoneal Neoplasms, run by Celgene 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 18 inclusion and 12 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: stopped early, as of the sponsor's last update on 18 Oct 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was stopped early (reason given: MTD not determined). Results are not available in the source record.

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?

Primary: Safety/tolerability endpoints are the maximum tolerated dose and dose-limiting toxicities (time frame: 18 months). 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 NCT00407407, which also lists 1 linked publication.

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 18 Oct 2019.

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