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Brenner TumorPhase 1NCT00079430

Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 1 study testing adjuvant therapy, paclitaxel and carboplatin in people with Brenner Tumor and Fallopian Tube Cancer, run by National Cancer Institute (NCI) at 19 sites in 2 countries.

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

This phase I trial is studying the side effects and best dose of adjuvant intraperitoneal carboplatin when given together with paclitaxel and bevacizumab in treating patients who have undergone debulking surgery for stage II , stage III, or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
adjuvant therapy, paclitaxel and carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
19 sitesin 2 countries
Study dates
Jun 2004to May 2011
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

  • Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Stage II-IV disease
  • The following histologic epithelial cell types are eligible:
  • Serous adenocarcinoma
  • Mucinous adenocarcinoma
  • Clear cell adenocarcinoma
Show all 67Show fewer
  • Transitional cell carcinoma
  • Adenocarcinoma not otherwise specified
  • Endometrioid adenocarcinoma
  • Undifferentiated carcinoma
  • Mixed epithelial carcinoma
  • Malignant Brenner's tumor
  • Optimal (≤ 1 cm residual disease) OR suboptimal residual disease after initial debulking surgery (performed within the past 12 weeks)
  • Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true:
  • Stage IB disease or less
  • Less than 3 mm invasion without vascular or lymphatic invasion
  • No poorly differentiated subtypes, including the following:
  • Papillary serous
  • Clear cell
  • Other FIGO grade 3 lesions
  • No epithelial tumors of low malignant potential (borderline tumors)
  • No CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases by history or evidence upon physical examination within the past 6 months
  • Performance status - GOG 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • INR ≤ 1.5
  • PTT < 1.2 times upper limit of normal (ULN)
  • No active bleeding or pathologic conditions carrying high risk of bleeding (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels)
  • AST ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • No acute hepatitis
  • Creatinine ≤ 2.0 mg/dL
  • Urine protein-creatinine ratio < 1.0 OR protein 1.0 g by 24 hour urine collection
  • Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided the patient's cardiac status has been stable for ≥ 6 months before study entry
  • No clinically significant cardiovascular disease, including any of the following:
  • Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
  • Myocardial infarction or unstable angina within the past 6 months
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Peripheral vascular disease ≥ CTCAE grade 2 (at least brief (< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit)
  • No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within the past 6 months
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of bevacizumab therapy
  • No neuropathy (sensory and motor) > grade 1
  • No active infection requiring antibiotics
  • No circumstances that would preclude study participation
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • No history of allergic reaction to polysorbate 80 (e.g., etoposide, vitamin E)
  • No other invasive malignancies within the past 5 years except non-melanoma skin cancer or localized breast cancer
  • No serious, non-healing wound, ulcer, or bone fracture
  • No significant traumatic injury within 28 days prior to bevacizumab therapy
  • No prior history of abdominal fistula or gastrointestinal perforation within the past 3-6 months
  • Granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection allowed but require weekly wound examinations
  • No clinical symptoms or signs of gastrointestinal obstruction requiring parenteral hydration and/or nutrition
  • At least 28 days since intra-abdominal abscess and recovered
  • At least 3 years since prior adjuvant chemotherapy for localized breast cancer
  • Patients must remain free of recurrent or metastatic disease
  • At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin
  • Patient must remain free of recurrent or metastatic disease
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • No concurrent amifostine or other protective agents
  • No concurrent major surgical procedure or open biopsy or within 28 days prior to bevacizumab therapy
  • No core biopsy within 7 days prior to bevacizumab therapy
  • No prior therapy for this malignancy
  • No prior cancer treatment that contraindicates study therapy
  • No prior anti-VEGF drug, including bevacizumab

Who cannot join

None listed.

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States17 sites

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • University of Chicago

    Chicago, Illinois, 60637

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of California Medical Center At Irvine-Orange Campus

    Orange, California, 92868

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Cancer Care Associates-Midtown

    Tulsa, Oklahoma, 74104

  • Tulsa Cancer Institute

    Tulsa, Oklahoma, 74146

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan2 sites

  • Kawasaki Medical School

    Okayama-Ken, Kurashiki, 701-0192

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

Other trials in Japan

About this study

Official title: A Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of Intraperitoneal Carboplatin (NSC #214240) and Intravenous Paclitaxel (NSC # 673089) and Intravenous Paclitaxel, Intraperitoneal Carboplatin and NCI Supplied Intravenous Bevacizumab (NSC #704865) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

This phase I trial is studying the side effects and best dose of adjuvant intraperitoneal carboplatin when given together with paclitaxel and bevacizumab in treating patients who have undergone debulking surgery for stage II , stage III, or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin and paclitaxel in treating ovarian epithelial or primary peritoneal cancer, or fallopian tube cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel during course 1, in patients with stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer who had initial debulking surgery.

II. Determine the feasibility of this regimen in these patients. III. Determine the feasibility of adding IV bevacizumab to this regimen in courses 2-6.

SECONDARY OBJECTIVES:

  1. Determine the toxicity profile of this regimen in these patients. II. Determine the toxicity profile of paclitaxel and bevacizumab IV in combination with intraperitoneal carboplatin in these patients.

III. Determine the response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal carboplatin.

Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-40 patients are treated at that dose level.

Patients are followed every 3 months for 1 year.

Medical subject headings
Brenner Tumor, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • adjuvant therapyProcedure or surgery

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given intraperitoneally

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

Study groups in NCT00079430
Study groupRoleWhat they receive
Treatment (adjuvant, paclitaxel, carboplatin, bevacizumab)ExperimentalPatients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Procedure: adjuvant therapy; Drug: paclitaxel; Drug: carboplatin; Biological: bevacizumab

What is being measured

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

  1. Maximum tolerated dose (MTD) of intraperitoneal carboplatin with intravenous paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)

    Measured: 3 weeks

  2. Incidence of adverse events in patients given intraperitoneal carboplatin with intravenous paclitaxel at the MTD, assessed by CTCAE v3.0

    Measured: 12 weeks

  3. Number of observed DLTs in patients given intraperitoneal carboplatin with intravenous paclitaxel and intravenous bevacizumab, graded using CTCAE v3.0

    Measured: 6 weeks

Secondary outcomes (3)

  1. Incidence of adverse events in patients given intraperitoneal carboplatin with intravenous paclitaxel and intravenous bevacizumab, graded using CTCAE v3.0

    Measured: 12 weeks

  2. Response rate (in patients with measurable disease who are in the expanded cohort) assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: Up to 1 year

  3. Progression-free survival assessed by RECIST

    Measured: From study entry until disease progression, death or date of last contact, up to 1 year

Timeline

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

  1. First posted10 Mar 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionMay 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00079430
Sponsor's protocol ID
NCI-2009-00620
Other IDs
NCI-2009-00620, GOG-9917, CDR0000355741, GOG-9917, GOG-9917, U10CA027469
Status last verified
Jul 2019
First submitted
8 Mar 2004
Last updated
22 Jul 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing adjuvant therapy, paclitaxel and carboplatin in people with Brenner Tumor and Fallopian Tube Cancer, run by National Cancer Institute (NCI) at 19 sites in 2 countries.

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 67 inclusion and 0 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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Japan. 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 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?

Maximum tolerated dose (MTD) of intraperitoneal carboplatin with intravenous paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) (time frame: 3 weeks). The study lists 3 primary outcomes in all. 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 NCT00079430.

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 22 Jul 2019.

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