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Fallopian Tube CancerPhase 1/2NCT00903630

Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

A Phase 1/2 study testing Lenalidomide and liposomal doxorubicin in people with Fallopian Tube Cancer and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota 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

RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, 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 only
What is being tested?
Lenalidomide and liposomal doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Apr 2009to Aug 2011
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histological diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer which has recurred or is resistant to prior treatment with at least one platinum based regimen and meeting at least one of the following criteria:
  • Platinum refractory - progression during the first six cycles of first line therapy with a platinum based regimen
  • Platinum resistant - progression within 6 months of completing first line platinum based chemotherapy
  • Platinum sensitive - progression more than 6 months of completing first line platinum based chemotherapy
  • Disease that has progressed while receiving or recurred within 6 months of completing platinum based second-line therapy Patients who have failed a second line therapy more than 6 months after completing treatment or have had more than 2 prior chemotherapy regimens will not be eligible for this study.
  • Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria defined as one or more lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as > or = 20 mm with conventional techniques (CT, PET/CT, MRI, X-ray) or as > or = 10 mm with spiral CT scan.
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  • Patients entering the study during the dose escalation component who do not meet the measurable disease requirement may enter with elevated CA 125 levels only if previously normal or stable CA 125 levels are documented after the completion of the prior chemotherapy regimen.
  • Age > or = 18 years at the time of signing of consent form
  • Gynecologic Oncology Group (GOG) performance status of < or = 2
  • Laboratory test results within these ranges within 14 days prior to study registration:
  • Absolute neutrophil count > or = 1.5 x 10^9/L
  • Platelet count > or = 100 x 10^9/L
  • Serum creatinine < or = 1.5 mg/dL
  • Total bilirubin < 1.2 mg/dL
  • AST (SGOT) and ALT (SGPT) < or = 2 x upper limit of institutional normal (ULN) or < or = 5 x ULN if hepatic metastases are present.
  • The left ventricular ejection fraction must be at or above the lower institutional limits of normal (as assessed by MUGA scan or echocardiogram) obtained within 28 days prior to registration.
  • Peripheral neuropathy ≤ grade 2 (CTCAE v 3.0).
  • Patients who are taking a stable or decreasing dose of concomitant systemic steroids during the study must agree to also take low dose aspirin and/or other platelet-active, anti-thrombotic medication (medication[s] used will be decided by the Investigator) while receiving study drug and for 30 days after study drug is discontinued.
  • All previous cancer therapy, including chemotherapy, hormonal therapy and surgery, must have been discontinued at least 28 days prior to treatment in this study. Use of thalidomide, or structurally related compounds, radiation, or biologic response modifiers must be discontinued at least 2 weeks prior to treatment in this study.
  • Progression free of prior malignancies for > or = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Who cannot join

  • Histologic diagnosis of borderline or low malignant potential epithelial carcinoma.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, would prevent the patient from signing the consent form.
  • Prior history of myocardial infarction, congestive heart failure, or arrhythmia requiring medication. History of uncontrolled hypertension. History of systolic or diastolic dysfunction. EKG evidence of ventricular hypertrophy, conduction abnormality, or serious arrhythmia.
  • History of deep vein thromboembolism (DVT) within the previous 6 months, history of thrombocytopenia or bleeding disorders.
  • Pregnant or breast feeding females. Lenalidomide is pregnancy category X.
  • Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if she were to participate in the study or confounds the ability to interpret data from the study.
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  • Use of any other experimental drug or therapy within 28 days of study registration.
  • Known hypersensitivity reaction > grade 2 to thalidomide or structurally related compounds
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
  • Any prior use of lenalidomide or liposomal doxorubicin
  • Concurrent use of other anti-cancer agents or treatments
  • Known positive for HIV or infectious hepatitis, type A, B or C
  • Uncontrolled hyper- or hypo- calcemia, glycosemia or thyroidism

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Minnesota Medical Center - Fairview

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Phase I/II Trial of Lenalidomide in Combination With Liposomal Doxorubicin for the Treatment of Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with doxorubicin hydrochloride liposome may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with doxorubicin hydrochloride liposome in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Read the detailed description

OBJECTIVES:

Phase I - Primary

  • To determine the maximum tolerated dose of lenalidomide when combined with fixed dose pegylated liposomal doxorubicin hydrochloride in women with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Phase II - Define the best overall response induced by lenalidomide in recurrent ovarian cancer patients

Secondary

  • To obtain preliminary information on toxicity, response, and time to progression (duration of response) of these patients.
  • Progression free survival

Phase I OUTLINE: This is a dose-escalation study of lenalidomide. Patients receive oral lenalidomide once daily on days 1-28 and pegylated liposomal doxorubicin hydrochloride intravenously (IV) on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Phase II OUTLINE: The phase II component will include patients with measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria treated at lenalidomide 10 mg days 1-28 days of a 28 day cycle (Maximum Tolerated Dose from phase I) with liposomal doxorubicin 40 mg/m^2 to determine efficacy and safety of the combination therapy. (Effective with April 2010 revision)

After completion of study therapy, patients are followed periodically.

Being tested
Lenalidomide, liposomal doxorubicin
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • LenalidomideDrug

    Also called Revlimid

    administered by mouth at the assigned dose daily for each 28 day cycle

  • liposomal doxorubicinDrug

    Also called Caelyx®

    administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

Study groups in NCT00903630
Study groupRoleWhat they receive
Phase 1 - Dose Level 1Experimentalliposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
Receives: Drug: Lenalidomide; Drug: liposomal doxorubicin
Phase I - Dose Level 2Experimentalliposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
Receives: Drug: Lenalidomide; Drug: liposomal doxorubicin
Phase 2Experimentalliposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
Receives: Drug: Lenalidomide; Drug: liposomal doxorubicin

What is being measured

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

  1. Phase 1 - Maximum Tolerated Dose (MTD) of Lenalidomide When Combined With Fixed Dose Liposomal Doxorubicin in Women With Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

    The maximum tolerated dose (MTD) reflects the highest dose of Lenalidomide when combined with fixed dose Liposomal Doxorubicin at which no more than one out of 6 participants experiences a dose limiting toxicity (DLT).

    Measured: 1 cycle (28 days)

  2. Phase 1 - Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

    DLT is defined as the inability to complete cycle 1 and/or begin cycle 2 within 7 days of the planned start due to a grade 4 or greater hemtologic toxicity or a grade 3 or greater non-hematologic toxicity. Grading was based on Common Toxicity Criteria (CTC) Version 4.

    Measured: within 5 weeks of starting treatment

  3. Phase 2 - Number of Subjects Achieving a Partial or Complete Response

    Partial response is defined as:

    At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.

    Complete response is defined as:

    The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.

    Measured: 3 months after starting treatment

Secondary outcomes (2)

  1. Phase 2 - Number of Subjects Who Are Progression-Free and Alive

    Progression is defined as:

    At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).

    Measured: 3 months after starting treatment

  2. Phase 2 - Number of Subjects Who Are Progression-Free and Alive

    Progression is defined as:

    At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurement, or the appearance of one or more new lesion(s).

    Measured: 6 months after starting treatment

Timeline

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

  1. First posted18 May 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionAug 2011
  4. Study completionAug 2011

Why it stopped: lack of funding

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00903630
Sponsor's protocol ID
2008LS047
Other IDs
0805M32463, WCC #50, RV-OVAR-PI-0447
Status last verified
Dec 2017
First submitted
15 May 2009
Last updated
28 Dec 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide and liposomal doxorubicin in people with Fallopian Tube Cancer and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota 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 24 inclusion and 13 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 28 Dec 2017. 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 18 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase 1 - Maximum Tolerated Dose (MTD) of Lenalidomide When Combined With Fixed Dose Liposomal Doxorubicin in Women With Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (time frame: 1 cycle (28 days)). 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 NCT00903630.

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 28 Dec 2017.

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