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Ovarian CancerPhase 2PRECEDENTNCT00722592

Platinum Resistant Ovarian Cancer Evaluation of Doxil and Vintafolide (MK-8109, EC145) Combination Therapy (8109-009, EC-FV-04)

A Phase 2 study testing Vintafolide, pegylated liposomal doxorubicin (PLD) and EC20 in people with Ovarian Cancer, run by Endocyte.

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

The objective of this study is to compare progression-free survival (PFS), based upon investigator assessment using Response Evaluation Criteria In Solid Tumors version 1.0 (RECIST 1.0) and clinical findings, in participants with platinum-resistant ovarian cancer who receive combination therapy with vintafolide and… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Vintafolide, pegylated liposomal doxorubicin (PLD) and EC20
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
No sites listed yet
Study dates
Sep 2008to Dec 2012
Phase
Phase 2
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

  • To qualify for randomization and treatment the following criteria must be met:
  • Subjects must sign an approved informed consent form
  • Subjects must be ≥ 18 years of age
  • Subjects must have pathology-confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
  • Subjects must have platinum-resistant ovarian cancer, where platinum-resistant is defined as disease that responded to primary platinum therapy and then progressed within 6 months or disease that progressed during or within 6 months of completing secondary platinum therapy
  • Subjects must have at least a single (RECIST-defined) measurable lesion on a radiological evaluation that is conducted no more than four weeks prior to beginning study therapy (EC145 and/or PLD).
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  • Subjects must have had prior debulking surgery
  • Subjects must have received prior platinum-based chemotherapy but must not have received more than 2 prior systemic cytotoxic regimens. Subjects are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for the management of recurrent or persistent disease. Non-cytotoxic (biologic or cytostatic) agents include, but are not limited to, monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction.
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Subjects must have recovered (to baseline/stabilization) from prior cytotoxic therapy-associated acute toxicities. Subjects who have recovered from non-cytotoxic therapy-associated toxicity or who have "controlled" non-cytotoxic therapy toxicity (e.g., vascular endothelial growth factor-related hypertension) can be entered into the trial after a drug wash-out period of 4 half lives
  • Subjects must have adequate organ function including:
  • Bone Marrow Reserve: Absolute neutrophil count(ANC)≥ 1.5x10^9/L prior to treatment. Subjects on maintenance doses of granulocyte colony stimulating factor (G-CSF) are eligible. Platelets ≥ 100x10^9/L and hemoglobin ≥ 9 g/dL.
  • Hepatic: Total bilirubin level < 1.5 x ULN and alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase(GGT), and alkaline phosphatase levels < 2.5 x ULN.
  • Renal: Serum creatinine level ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min/1.73m^2 for subjects with serum creatinine levels above 1.5 x ULN.
  • Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater than
  • the institutional lower limit of normal. LVEF must be elevated within 90 days prior to Cycle 1 Day 1
  • Subjects of childbearing potential must:
  • Have a negative serum pregnancy test prior to initiation of the therapeutic regimen
  • Practice an effective method of birth control (e.g., oral, transdermal or injectable contraceptives, intrauterine device, double-barrier contraception, such as diaphragm and spermicidal jelly) for the duration of their participation in the trial through 3 months following the last dose of study drug.

Who cannot join

  • The presence of any of the following will exclude the subject from the study:
  • Diagnosis of tumor of low-malignant potential
  • Prior exposure to PLD or anthracycline therapy
  • Prior exposure to FR-targeted therapy (EC145, EC0225, farletuzumab, etc)
  • Prior therapy with mouse antibodies
  • Prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds
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  • Prior abdominal or pelvic radiation therapy, radiation therapy to > 10% of the bone marrow, or prior radiation therapy within the past 3 years to the breast/sternum, dermal lesions, head or neck
  • Recent (i.e., ≤ 6 weeks) history of abdominal surgery or peritonitis
  • Serious comorbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure or recent myocardial infarction. Subjects who require antifolate therapy for the management of comorbid conditions (e.g., rheumatoid arthritis) will be excluded from the trial.
  • Pregnancy
  • Concurrent malignancy or history of other cancer (except noninvasive skin cancer) within the last 5 years
  • Symptomatic central nervous system metastasis
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Use of low dose corticosteroid therapy (for nausea prophylaxis, etc) is acceptable; however, concomitant tamoxifen therapy is not. Supportive care measures are allowed.

About this study

Official title: A Randomized Phase II Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil/Caelyx) in Combination, Versus PLD Alone, in Subjects With Platinum-Resistant Ovarian Cancer

The objective of this study is to compare progression-free survival (PFS), based upon investigator assessment using Response Evaluation Criteria In Solid Tumors version 1.0 (RECIST 1.0) and clinical findings, in participants with platinum-resistant ovarian cancer who receive combination therapy with vintafolide and pegylated liposomal doxorubicin (PLD/Doxil®/Caelyx®) with that in subjects with platinum-resistant ovarian cancer who receive PLD alone.

Read the detailed description

This is a Phase II clinical trial to evaluate the efficacy and safety of the combination of vintafolide and pegylated liposomal doxorubicin (PLD; available in the United States as Doxil® and outside the United States as Caelyx®) compared to PLD alone.

Vintafolide is a drug that is specifically designed to enter cancer cells via the folate vitamin receptor (FR). Experimental evidence shows that this target receptor is expressed on virtually all ovarian cancers. Early clinical evidence in a small number of Phase I subjects and in a subset of subjects in an on-going single-arm Phase II study suggests that vintafolide may have antitumor effect in women with advanced ovarian cancer and that it is generally well-tolerated. This evidence suggests that vintafolide may be useful as chemotherapy against advanced ovarian cancer.

Patients at centers with EC20 imaging capability will also undergo imaging with the folate receptor (FR-)targeting investigational diagnostic agent EC20 during the screening period to assess uptake of this agent into tumors. This non-invasive procedure will provide additional information on the utility of EC20 imaging to identify subjects with the FR molecular "target" before treatment with vintafolide therapy.

Conditions
Ovarian Cancer
Being tested
Vintafolide, pegylated liposomal doxorubicin (PLD), EC20
Keywords
cancer, ovarian, platinum-resistant, Phase II, EC145, EC20
Medical subject headings
Ovarian Neoplasms, Neoplasms

What participants receive

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

  • VintafolideDrug

    Also called EC145

    2.5 mg IV bolus on Days 1,3,5 and 15,17,19 of a 4-week cycle

  • pegylated liposomal doxorubicin (PLD)Drug

    Also called Doxil®, Caelyx®

    50 mg/m^2 (with dose based on ideal body weight for participants whose measured body weight is greater than their ideal body weight) intravenous infusion on Day 1 of a 4 week cycle. Dose reductions permitted for toxicity.

  • EC20Other

    Also called 99mTc-EC20

    During the screening period, participants at centers with EC20 imaging capability will receive a single intravenous injection of 0.1 mg EC20 labeled with 20-25 mCi technetium-99m followed by an imaging procedure. A second injection and imaging may be done after all therapy with the study drugs is done.

Study groups in NCT00722592
Study groupRoleWhat they receive
Vintafolide + PLDExperimentalParticipants receive vintafolide 2.5 mg intravenous (IV) bolus on Days 1, 3, 5, 15, 17, and 19 and Pegylated Liposomal Doxorubicin (PLD) weight-based dose, IV on Day 1 of each 4-week cycle.
Receives: Drug: Vintafolide; Drug: pegylated liposomal doxorubicin (PLD); Other: EC20
PLD AloneActive comparatorParticipants receive PLD on Day 1 of each 4-week cycle.
Receives: Drug: pegylated liposomal doxorubicin (PLD); Other: EC20

What is being measured

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

  1. Progression-free survival based on investigator assessment using RECIST and clinical findings

    Measured: Assessed within 12 months following completion of accrual

Secondary outcomes (4)

  1. Compare overall survival of subjects between the two treatment arms

    Measured: Assessed within 18 months after initiation of PFS analysis

  2. Evaluate the safety and tolerability of EC145 in combination with PLD

    Measured: event driven

  3. Compare objective response rate (ORR) and duration of response of EC145 in combination with PLD, versus PLD alone, based on investigator assessment when analyzed using RECIST.

    Measured: event-driven

  4. Explore the correlation between therapeutic response (e.g. PFS, radiologic response, etc) and 99mTc-EC20 levels

    Measured: Assessed within 12 months following completion of accrual

Timeline

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

  1. First posted25 Jul 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionSep 2010
  4. Study completionDec 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00722592
Sponsor's protocol ID
8109-009
Other IDs
EC-FV-04
Acronym
PRECEDENT
Status last verified
Dec 2014
First submitted
23 Jul 2008
Last updated
7 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.

    PubMed 37407274

  • Naumann RW, Coleman RL, Burger RA, Sausville EA, Kutarska E, Ghamande SA, Gabrail NY, Depasquale SE, Nowara E, Gilbert L, Gersh RH, Teneriello MG, Harb WA, Konstantinopoulos PA, Penson RT, Symanowski JT, Lovejoy CD, Leamon CP, Morgenstern DE, Messmann RA. PRECEDENT: a randomized phase II trial comparing vintafolide (EC145) and pegylated liposomal doxorubicin (PLD) in combination versus PLD alone in patients with platinum-resistant ovarian cancer. J Clin Oncol. 2013 Dec 10;31(35):4400-6. doi: 10.1200/JCO.2013.49.7685. Epub 2013 Oct 14.

    PubMed 24127448

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vintafolide, pegylated liposomal doxorubicin (PLD) and EC20 in people with Ovarian Cancer, run by Endocyte.

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 19 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: finished, as of the sponsor's last update on 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

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 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?

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?

Progression-free survival based on investigator assessment using RECIST and clinical findings (time frame: Assessed within 12 months following completion of accrual). 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 NCT00722592, which also lists 2 linked publications.

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 7 Jan 2015.

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PRECEDENT Clinical Trial NCT00722592 | AzTrials