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Ovarian CancerPhase 2NCT00610792

Phase 2 Study of Twice Weekly VELCADE and CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens

A Phase 2 study testing bortezomib and pegylated liposomal doxorubicin in people with Ovarian Cancer, run by Millennium Pharmaceuticals, Inc. at 7 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This a Phase 2, multicenter open label, uncontrolled 2-step design. Patients will be arranged in two groups based upon the response to their last platinum containing therapy. The two groups are, 1) Platinum Resistant Patients: patients with progressive disease while on platinum containing therapy or stable disease… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
bortezomib and pegylated liposomal doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
7 sitesin 2 countries
Study dates
Jul 2006to Sep 2009
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically/cytologically confirmed diagnosis of ovarian carcinoma of epithelial origin, primary tubal or peritoneal carcinoma;
  • Progressive or recurrent disease
  • The following patient types based upon the disease measurability may enroll in this study and will be considered for efficacy evaluation.
  • Patients may have measurable disease strictly following the RECIST guidelines. CA125 levels must be obtained according to the Rustin guidelines to enable a complete evaluation of response/progressive disease according to the GCIG guidelines. Patients may enter with a solitary measurable lesion which has not been confirmed by histology/cytology. These patients will be considered evaluable for response according to a modified RECIST which will not require the histological/cytological confirmation of the lesion. CA125 levels must be obtained according to the Rustin guidelines to enable a complete evaluation of progressive disease according to the GCIG guidelines. Patients with non-measurable disease will be considered evaluable for response provided CA125 data has been collected according to the Rustin guidelines and a complete evaluation of response/progressive disease according to the GCIG guidelines maybe conducted.
  • Numbers of prior chemotherapy(s): maximum 2 prior chemotherapies. Reintroduction of a platinum at relapse, after an initial response lasting > 6 months is considered 1 chemotherapy regimen only.
  • ECOG performance status grade 0 or 1
Show all 12Show fewer
  • Age ≥ 18 and ≤ 75 yrs
  • Adequate hematological, liver and renal function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1.50 x 109/L; platelets ≥ 100 x 109/L, bilirubin within UNL; alkaline phosphatase ≤ 1.5 x UNL; ALT, AST ≤ UNL or ≤ 2.5 x UNL in case of liver metastases; albumin ≥ 2.5 g/dL; creatinine ≤ UNL
  • Life expectancy of at least 3 months
  • Prior anthracycline limited to doxorubicin equivalent of 280mg/m2 with progression free interval of at least 12 months for patients who have been pre-treated with CAELYX
  • LVEF must be within normal limits
  • Signed and dated informed consent

Who cannot join

  • Chemotherapy, hormonal, radiation or immunotherapy or participation in any investigational drug study within 4 weeks of study entry
  • Pre-existing peripheral neuropathy > Grade 1
  • Presence of cirrhosis or active or chronic hepatitis
  • Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorder
  • Presence of uncontrolled intercurrent illness or any condition which in the judgment of the Investigator would place the subject at undue risk or interfere with the results of the study
  • Symptomatic brain metastases or leptomeningeal disease
Show all 9Show fewer
  • Pregnancy or lactation or unwillingness to use adequate method of birth control
  • Active infection
  • Known history of allergy to mannitol, boron or liposomally formulated drugs.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Italy4 sites

  • Division of Gynecologic Oncology, Università Catholica Sacre Cuore

    Campbasso

  • Istituto Europeo di Oncologia (IEO)

    Milan

  • Istituto Nazionale dei Tumori

    Milan

  • Dept. Procreational Medicine, Università di Pisa

    Pisa

Other trials in Italy

Switzerland3 sites

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona

  • Gynecologic Oncology Unit

    Ospedale Sant' Anna, Turin

  • Kantonsspital St. Gallen

    Sankt Gallen, CH

Other trials in Switzerland

About this study

Official title: An Open Label, Phase 2 Study of Biweekly VELCADE and Intermittent CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens

This a Phase 2, multicenter open label, uncontrolled 2-step design. Patients will be arranged in two groups based upon the response to their last platinum containing therapy. The two groups are, 1) Platinum Resistant Patients: patients with progressive disease while on platinum containing therapy or stable disease after at least 4 cycles; patients relapsing following an objective response while still receiving treatment; patients relapsing after an objective response within 6 months from the discontinuation of the last chemotherapy and 2) Platinum-Sensitive Patients: patients who relapsed following an objective response after 6 months from the discontinuation of platinum containing chemotherapy. All patients will receive pyridoxine at least 200mg by mouth daily beginning approximately one week prior to the initiation of the combination chemotherapy and it will continue up to the end of the last treatment cycle.

Conditions
Ovarian Cancer
Being tested
bortezomib, pegylated liposomal doxorubicin
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • bortezomibDrug

    Also called VELCADE

    1.3 mg/m2 on Days 1, 4, 8 \& 11 every 3 weeks (1 cycle = 21 days) for up to six cycles

  • pegylated liposomal doxorubicinDrug

    Also called CAELYX

    30 mg/m2 on Day 1 every 3 weeks (1 cycle = 21 days) for up to six cycles

Study groups in NCT00610792
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: bortezomib; Drug: pegylated liposomal doxorubicin

What is being measured

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

  1. tumor response, as measured using the Gynecologic Cancer Intergroup (GCIG) recommendations (modified RECIST); duration of response and progression free interval

    Measured: baseline scans performed up to 4 weeks prior to start of treatment; further assessments at end of cycle 2; confirmation is required

Secondary outcomes (1)

  1. Overall safety profile of the combination characterized by type, frequency, severity, timing and relationship to study therapy of adverse events and laboratory abnormalities (NCI-CTCAE V3.0)

    Measured: Patients followed for adverse events for 30 days after the last drug administration, or until all drug related toxicities and ongoing SAEs havebeen resolved

Timeline

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

  1. First posted8 Feb 2008 (estimated)
  2. Study startJul 2006
  3. Primary completionSep 2009 (estimated)

Why it stopped: Study never submitted to IND. Study is being sponsored by Johnson and Johnson in the EU only.

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00610792
Sponsor's protocol ID
26866138-OVC-2001
Other IDs
S043VELC02
Status last verified
Jul 2009
First submitted
28 Jan 2008
Last updated
14 Jul 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib and pegylated liposomal doxorubicin in people with Ovarian Cancer, run by Millennium Pharmaceuticals, Inc. at 7 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 12 inclusion and 9 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: withdrawn, as of the sponsor's last update on 14 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy, Switzerland. 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 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 was withdrawn before enrolling participants, so there are no results.

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?

tumor response, as measured using the Gynecologic Cancer Intergroup (GCIG) recommendations (modified RECIST); duration of response and progression free interval (time frame: baseline scans performed up to 4 weeks prior to start of treatment; further assessments at end of cycle 2; confirmation is required). 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 NCT00610792.

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 14 Jul 2009.

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