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Brenner TumorPhase 1NCT00085358

Carboplatin and Paclitaxel With or Without Bevacizumab Compared to Docetaxel, Carboplatin, and Paclitaxel in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Carcinoma (Cancer)

A Phase 1 study testing carboplatin, paclitaxel and docetaxel in people with Brenner Tumor and Fallopian Tube Cancer, run by National Cancer Institute (NCI) at 16 sites 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

This phase I trial is studying the side effects and best dose of intraperitoneal infusions of carboplatin when given together with intravenous infusions of either docetaxel or paclitaxel followed by intraperitoneal paclitaxel in treating patients with stage II, stage III, or stage IV ovarian epithelial, fallopian… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
carboplatin, paclitaxel and docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
16 sitesUnited States
Study dates
May 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 fallopian tube, ovarian epithelial, or primary peritoneal carcinoma
  • Stage II-IV disease
  • The following epithelial cell types are allowed:
  • Carcinosarcoma
  • Serous adenocarcinoma
  • Endometrioid adenocarcinoma
Show all 68Show fewer
  • Mucinous adenocarcinoma
  • Undifferentiated carcinoma
  • Clear cell adenocarcinoma
  • Mixed epithelial carcinoma
  • Transitional cell carcinoma
  • Malignant Brenner's tumor
  • Adenocarcinoma not otherwise specified
  • Must have undergone prior surgery for ovarian or peritoneal carcinoma within the past 12 weeks
  • Optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery
  • Must have a procedure for determining diagnosis of ovarian/peritoneal carcinoma with appropriate tissue for histologic evaluation
  • Synchronous primary endometrial cancer or prior endometrial cancer allowed provided the following criteria are met:
  • Stage ≤ IB
  • Less than 3 mm invasion without vascular or lymphatic invasion
  • No poorly differentiated subtypes (e.g., grade 3, clear cell, or papillary serous)
  • No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
  • No CNS disease (e.g., seizures not controlled with standard medical therapy) or metastasis
  • GOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • INR ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus) (applies to part C only)
  • PTT < 1.2 times the upper limit of normal (applies to part C only)
  • SGOT ≤ 2.5 times normal
  • Alkaline phosphatase ≤ 2.5 times normal
  • Bilirubin ≤ 1.5 times normal
  • Creatinine ≤ 1.5 times normal
  • No active bleeding
  • Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided disease has remained stable for the past 6 months
  • No unstable angina or myocardial infarction within the past 6 months
  • No neuropathy (sensory and motor) > CTCAE grade 1
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy
  • No septicemia, severe infection, or acute hepatitis
  • No other invasive malignancy within the past 5 years except non-melanoma skin cancer or localized breast cancer
  • No circumstance that would preclude study participation
  • No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E)
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies (applies to part C only)
  • No clinically significant proteinuria
  • Must have urine protein-creatinine ratio (UPCR) < 1
  • No serious, non-healing wound, ulcer, or bone fracture (applies to part C only)
  • At least 3-6 months since prior abdominal fistula or gastrointestinal perforation and fully recovered (part C only)
  • No history of intra-abdominal abscess within the past 28 days (applies to part C only)
  • No active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels (applies to part C only)
  • No history or evidence (upon physical examination) of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases (applies to part C only)
  • No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study (applies to part C only)
  • No significant traumatic injury within 28 days (applies to part C only)
  • No clinically significant cardiovascular disease, including any of the following (applies to part C only):
  • Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
  • Myocardial infarction or unstable angina < 6 months prior to registration
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • CTCAE Grade 2 or greater peripheral vascular disease (at least brief (< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit)
  • History of CVA within the past six months
  • No clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition (applies to part C only)
  • No prior therapy with any anti-VEGF drug, including bevacizumab (applies to part C only)
  • No prior chemotherapy
  • Prior adjuvant chemotherapy for localized breast cancer allowed provided the therapy was completed at least 3 years before registration to study and the patient remains free of recurrent or metastatic disease
  • No prior radiotherapy
  • No prior cancer therapy that would contraindicate study treatment
  • No anticipation of invasive procedures, including any of the following (applies to part C only):
  • Major surgical procedure or open biopsy within 28 days prior to the first date of bevacizumab therapy (cycle 2)
  • Major surgical procedure anticipated during the course of the study
  • Core biopsy within 7 days prior to the first date of bevacizumab therapy

Who cannot join

None listed.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Colorado Gynecologic Oncology Group

    Aurora, Colorado, 80010

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Johns Hopkins University

    Baltimore, Maryland, 21287-8936

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of California Medical Center At Irvine-Orange Campus

    Orange, California, 92868

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Cancer Care Associates-Midtown

    Tulsa, Oklahoma, 74104

  • Cancer Care Associates-Yale

    Tulsa, Oklahoma, 74136-1929

Other trials in United States

About this study

Official title: A Phase I Trial of Intravenous Paclitaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Docetaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Paclitaxel, Intraperitoneal Carboplatin, Intraperitoneal Paclitaxel and CTEP-Supplied Agent Bevacizumab (NSC 704865, IND 7921) in Patients With Previously Untreated Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

This phase I trial is studying the side effects and best dose of intraperitoneal infusions of carboplatin when given together with intravenous infusions of either docetaxel or paclitaxel followed by intraperitoneal paclitaxel in treating patients with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma (cancer). Drugs used in chemotherapy, such as carboplatin, docetaxel, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells

Read the detailed description

OBJECTIVES:

  1. Determine the maximum tolerated dose (MTD) of intraperitoneal (IP) carboplatin when given in combination with IV paclitaxel followed by IP paclitaxel in patients with stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma.

II. Determine the MTD of IP carboplatin and IV docetaxel when given in combination with IP paclitaxel in these patients.

III. To determine the feasibility of the combination of IV paclitaxel, IP carboplatin and IV bevacizumab on day one followed by IP paclitaxel on day eight (Part C Only).

IV. Determine the dose-limiting toxic effects and complications in patients treated with these regimens.

  1. Evaluate the neurotoxicity of this regimen at each cycle using the FACT/GOG-NTX4 assessment tool to determine dose reduction in these patients.

VI. Evaluate the techniques used for intraperitoneal catheter placement, surgical procedures, and reporting of outcomes in these patients.

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

Patients in the dose-escalation phase are not eligible to enter the feasibility phase.

DOSE-ESCALATION PHASE (PART A or PART B): Patients receive IP carboplatin on day 1, and paclitaxel IV over 3 hour (part A) or docetaxel IV over 1 hour (Part B) on day 1, and IP paclitaxel on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

FEASIBILITY PHASE (PART C): Patients receive IP carboplatin on day 1, paclitaxel IV on day 1, and IP paclitaxel on day 8 in course 1 as in part A dose-escalation phase. Beginning in course 2 and all subsequent courses, patients receive IP carboplatin on day 1, IV paclitaxel on day 1, and IP paclitaxel on day 8 as in the dose-escalation phase, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

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.

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given intraperitoneally

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV or intraperitoneally

  • docetaxelDrug

    Also called RP 56976, Taxotere, TXT

    Given IV

  • bevacizumabBiological

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

    Given IV

Study groups in NCT00085358
Study groupRoleWhat they receive
Treatment (carboplatin, paclitaxel, docetaxel, bevacizumab)ExperimentalPatients receive IP carboplatin on day 1, and paclitaxel IV over 3 hour (part A) or docetaxel IV over 1 hour (Part B) on day 1, and IP paclitaxel on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive IP carboplatin on day 1, paclitaxel IV on day 1, and IP paclitaxel on day 8 in course 1 as in part A dose-escalation phase. Beginning in course 2 and all subsequent courses, patients receive IP carboplatin on day 1, IV paclitaxel on day 1, and IP paclitaxel on day 8 as in the dose-escalation phase, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: carboplatin; Drug: paclitaxel; Drug: docetaxel; 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 IV paclitaxel with IP carboplatin followed by IP 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. MTD of IV docetaxel with IP carboplatin followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0

    Measured: 3 weeks

  3. MTD of IV paclitaxel with IP carboplatin and IV bevacizumab followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0

    Measured: 3 weeks

Secondary outcomes (3)

  1. Incidence of adverse events in patients given IV paclitaxel with IP carboplatin followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0

    Measured: 12 weeks

  2. Incidence of adverse events in patients given of IV docetaxel with IP carboplatin followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0

    Measured: 12 weeks

  3. Incidence of adverse events in patients given IV paclitaxel with IP carboplatin and IV bevacizumab followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0

    Measured: 12 weeks

Timeline

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

  1. First posted11 Jun 2004 (estimated)
  2. Study startMay 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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00085358
Sponsor's protocol ID
NCI-2009-00619
Other IDs
GOG-9916, U10CA027469
Status last verified
Jul 2019
First submitted
10 Jun 2004
Last updated
22 Jul 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing carboplatin, paclitaxel and docetaxel in people with Brenner Tumor and Fallopian Tube Cancer, run by National Cancer Institute (NCI) at 16 sites 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 68 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 16 sites 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 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 IV paclitaxel with IP carboplatin followed by IP 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 NCT00085358.

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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