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Fallopian Tube CancerPhase 1NCT01281514

A Study of Carboplatin, PLD and Everolimus in Certain Gynecologic Cancer

A Phase 1 study testing everolimus, carboplatin and pegylated liposomal doxorubicin hydrochloride in people with Fallopian Tube Cancer and Peritoneal Cavity Cancer, run by Fox Chase Cancer Center 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

RATIONALE: Drugs used in chemotherapy, such as carboplatin and pegylated liposomal doxorubicin hydrochloride (PLD) work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
everolimus, carboplatin and pegylated liposomal doxorubicin hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
14 Dec 2010to 8 Jan 2018
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
  • Patients must have had exactly one prior platinum/taxane-based chemotherapeutic regimen for management of primary disease, and must be in first relapse; first relapse must occur >= six months from completion of front-line platinum-based therapy; (time measured from last platinum dose; for example, patients receiving a biologic or chemotherapeutic agent after completion of platinum-based therapy as part of upfront therapy would be eligible based on time from last dose of platinum chemotherapy; in this situation, patients must be at least four weeks from last dose of a biologic agent); relapse cannot be based on rising cancer antigen (CA)- 125 alone; there must be radiographic evidence of recurrent disease
  • Measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria or non-measurable disease with symptomatic malignant pleural effusion or malignant ascites; if only site of disease is a pleural effusion, cytologic confirmation of recurrence should be obtained
  • Patients must not have any major surgery or radiation therapy within 14 days of start of study treatment
  • All acute toxicities from prior therapy with the exception of alopecia must have resolved to =< grade 1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
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  • Absolute neutrophil count (ANC) >= 1500
  • Platelets >= 100K
  • Serum total bilirubin =< 1.5x upper limit of normal (ULN)
  • Serum transaminase (aspartate aminotransferase [AST]/serum glutamic oxaloacetic transaminase [SGOT], alanine aminotransferase [ALT]/serum glutamic pyruvic transaminase [SGPT]) activity =< 2.5 x ULN
  • International normalized ratio (INR) =< 1.5 and partial thromboplastin time (PTT) =< 1.5 x ULN for patients who are not being treated with therapeutic anticoagulation; therapeutic or prophylactic anticoagulation is allowed if a patient has been on a stable dose of low molecular weight (LMW) heparin for > 2 weeks at the time of randomization; subjects on therapeutic or prophylactic anticoagulation including warfarin will have PTT and INR as determined by the Investigator; prophylactic use of an anticoagulant to maintain patency of a vascular access device is also allowed)
  • Serum creatinine =< 2.0
  • Creatinine clearance > 60 ml/min
  • Left ventricular ejection fraction (LVEF) > lower limit of normal (LLN) on multi gated acquisition scan (MUGA)
  • Ability to understand and willingness to sign a written informed consent document
  • Ability to take oral medication
  • Fasting serum cholesterol < 300 mg/dL and triglycerides < 2.5 x ULN; Note: in case one or both of these thresholds are exceeded, the patient can be included after initiation of appropriate lipid lowering medication if on repeat analysis, both levels fall within parameters
  • Able and willing to comply with testing and treatment as outlined in this protocol

Who cannot join

  • Patients with more than one prior chemotherapy regimen for management of primary disease
  • Patients who have received a prior mammalian target of rapamycin (mTOR) inhibitor
  • Chronic treatment with systemic steroids or other immunosuppressive agents; Note: topical or inhaled steroids are allowed
  • Uncontrolled brain or leptomeningeal metastases, including those who continue to require glucocorticoids for brain or leptomeningeal metastases
  • Other malignancies =< 3 years prior to registration except for adequately treated carcinoma of the cervix or basal or squamous carcinomas of the skin
  • Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study; examples include, but are not limited to: uncontrolled diabetes defined as fasting serum glucose > 1.5 x ULN; uncontrolled hypertension, or greater than 150/100 in spite of antihypertensive therapy; active (acute or chronic) or uncontrolled severe infection; unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association Class III or IV); ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months; liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
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  • Known history of human immunodeficiency virus (HIV) seropositivity as these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy and the potential pharmacokinetic interaction between antiretroviral therapy and the investigational agent
  • Known history of Hepatitis B or C as these patients may be at risk of disease reactivation when treated with the chemotherapy and/or the investigational agent
  • Patients should not receive immunization with attenuated live vaccines =< 7 days of study entry or during study period
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection sufficient to impair absorption of drug)
  • Patients with clinical symptoms of gastrointestinal obstruction and who require parenteral hydration/nutrition
  • Patients with an active bleeding diathesis
  • Women who are pregnant or breast-feeding, or women able to conceive and unwilling to practice an effective method of birth control; (women of childbearing potential must have a negative urine or serum pregnancy test within =< 7 days prior to administration of RAD001); oral, implantable or injectable contraceptives may be affected by cytochrome P450 interactions and are therefore not considered effective for this study
  • History of noncompliance with medical regimens
  • Patients with a known hypersensitivity to any of the study agents
  • Patients unwilling or unable to comply with the outlined protocol
  • Patients with psychiatric illness or social situations that would limit compliance with study requirements

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

Official title: Phase I Study of Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Everolimus in Patients With Platinum-Sensitive Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer in First Relapse

RATIONALE: Drugs used in chemotherapy, such as carboplatin and pegylated liposomal doxorubicin hydrochloride (PLD) work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving carboplatin and PLD together with everolimus may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with carboplatin and PLD in treating patients with relapsed ovarian epithelial, fallopian tube, or peritoneal cavity cancer

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose (MTD) of RAD001 (everolimus) in combination with carboplatin and PLD.

SECONDARY OBJECTIVES:

  1. Determine safety/tolerability of the three drug combination of carboplatin, PLD and RAD001 (everolimus).

II. Determine preliminary analysis of anti-tumor activity of this regimen in patients with recurrent ovarian, fallopian tube or primary peritoneal cancers.

OUTLINE: This is a dose-escalation study of everolimus.

Patients receive carboplatin intravenously (IV) and PLD IV on day 1 and everolimus orally (PO) once daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 1 year.

Being tested
everolimus, carboplatin, pegylated liposomal doxorubicin hydrochloride, laboratory biomarker analysis
Medical subject headings
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.

  • everolimusDrug

    Also called 42-O-(2-hydroxy)ethyl rapamycin, Afinitor, RAD001

    Given PO

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • pegylated liposomal doxorubicin hydrochlorideDrug

    Also called CAELYX, Dox-SL, DOXIL, doxorubicin hydrochloride liposome

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01281514
Study groupRoleWhat they receive
TreatmentExperimentalSee Detailed Description
Receives: Drug: everolimus; Drug: carboplatin; Drug: pegylated liposomal doxorubicin hydrochloride; Other: laboratory biomarker analysis

What is being measured

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

  1. MTD of RAD001 in combination with carboplatin and pegulated liposomal doxorubicin

    Determine the MTD of RAD001 (everolimus) in combination with carboplatin and pegylated liposomal doxorubicin. The MTD is defined as the dose level closest to, but not over that which is predicted to result in a DLT rate of 30%, the target toxicity.

    Measured: About 24 weeks

Secondary outcomes (2)

  1. Safety/tolerability of the three drug combination of carboplatin, PLD and RAD001 based on Common Terminology Criteria for Adverse Events (CTCAE) v4.0

    Determine safety/tolerability of the three drug combination of carboplatin, PLD and RAD001. Determine preliminary analysis of anti-tumor activity of this regimen in patients with recurrent ovarian, fallopian tube or primary peritoneal cancers.

    Measured: Every 28 days and when patient is removed from study for any reason

  2. Preliminary analysis of anti-tumor activity of this regimen in patients with recurrent ovarian, fallopian tube or primary peritoneal cancers

    Measured: Baseline and every 28 days

Timeline

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

  1. First posted24 Jan 2011 (estimated)
  2. Study start14 Dec 2010
  3. Primary completion8 Jan 2018
  4. Study completion8 Jan 2018

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01281514
Sponsor's protocol ID
IRB 10-019
Other IDs
NCI-2011-00055, GYN-067
Status last verified
Jul 2019
First submitted
12 Jan 2011
Last updated
11 Jul 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing everolimus, carboplatin and pegylated liposomal doxorubicin hydrochloride in people with Fallopian Tube Cancer and Peritoneal Cavity Cancer, run by Fox Chase Cancer Center 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 17 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 11 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 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 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?

MTD of RAD001 in combination with carboplatin and pegulated liposomal doxorubicin (time frame: About 24 weeks). 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 NCT01281514.

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 11 Jul 2019.

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