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Epithelial Ovarian CancerPhase 1/2NCT01238770

Phase I/II Study of Pazopanib and Cyclophosphamide in Patients With Platinum-resistant Recurrent Ovarian Cancer

A Phase 1/2 study testing Pazopanib in people with Epithelial Ovarian Cancer, run by Priv.-Doz. Dr. med. Joachim Rom at 5 sites in Germany.

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 current trial shall clarify the potential of the multitarget antiangiogenic tyrosinkinase inhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as salvage treatment in patients with recurrent, pretreated ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
Pazopanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
5 sitesGermany
Study dates
Nov 2010to Oct 2015
Phase
Phase 1/2
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

  • Written informed consent
  • Female subjects ≥18 years of age
  • Histologically or cytologically confirmed diagnosis of: epithelial ovarian cancer which is platinum resistant or platinum refractory,cancer of the fallopian tube, peritoneal cancer
  • Patients must have failed available standard chemotherapy regimen
  • Prior treatment with at least 2 chemotherapy regimens in advanced tumor setting
  • Performance status ECOG 0 - 2
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  • Adequate contraception
  • Adequate organ function
  • Measurable disease according to RECIST criteria.
  • Able to swallow and retain oral medication.
  • Life expectancy of at least 12 weeks.

Who cannot join

  • Any second malignancy within the last 5 years, with the exception of basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug.
  • Clinically significant gastrointestinal abnormalities which might interfere with oral dosing
  • Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
  • Prolongation of corrected QT interval (QTc) >480 msecs.
  • History of any one or more of the following cardiovascular conditions within the past 6 months:
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  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • Symptomatic peripheral vascular disease
  • Coronary artery by-pass graft surgery
  • Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
  • History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
  • Macroscopic hematuria
  • Hemoptysis that is clinically relevant within 4 weeks of first dose of study drug
  • Evidence of active bleeding or bleeding diathesis
  • Known endobronchial lesions or involvement of large pulmonary vessels by tumor
  • Prior major surgery or trauma within 14 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
  • Chemotherapy or radiation therapy within 2 weeks prior to the first dose of study drug.
  • Biological therapy, hormonal therapy or treatment with an investigational agent within 28 days or 5 half-lives
  • Prior antiangiogenic therapy.
  • Is unable or unwilling to discontinue predefined prohibited medications listed in the protocol for 14 days or five half-lives of a drug (whichever is longer) prior to Visit 1 and for the duration of the study
  • Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Pregnancy
  • More than 3 different chemotherapy regimens in advanced tumor setting
  • Uncontrolled hypertension
  • History of ischemic event (stroke, myocardial infarction, unstable angina, TIA, symptomatic peripheral vascular disease)
  • History or clinical evidence of thrombo-embolic event
  • History of haemoptysis, cerebral, or clinically significant gastrointestinal haemorrhage in the past 6 months
  • Active bleeding
  • Signs/Suspicion of intestinal obstruction

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Marienkrankenhaus Hamburg

    Hamburg, 22087

  • Universitäts-Frauenklinik

    Heidelberg, 69120

  • Klinikum Konstanz Gynäkologie und Geburtshilfe

    Konstanz, 78464

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik und Poliklinik für Geburtshilfe und Frauenheilkunde

    Mainz, 55131

  • Universitätsfrauenklinik Tübingen Klinik für Gynäkologie und Geburtshilfe

    Tübingen, 72076

Other trials in Germany

About this study

Official title: A Phase I/II Study of Pazopanib (GW786034) and Cyclophosphamide in Patients With Platinum-resistant Recurrent, Pre-treated Ovarian Cancer

The current trial shall clarify the potential of the multitarget antiangiogenic tyrosinkinase inhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as salvage treatment in patients with recurrent, pretreated ovarian cancer.

Read the detailed description

This study is a prospective open-label, non-randomized multicenter phase I/II trial in order to determine overall response rate of patients with platinum-resistant or refractory recurrent, pretreated epithelial ovarian cancer.

In order to assure adequate toxicity assessment, a phase-I-trial is proponed. Phase II will be performed with MTD.

Being tested
Pazopanib
Keywords
Ovarian cancer
Medical subject headings
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms

What participants receive

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

  • PazopanibDrug

    Also called Cyclophosphamid

    Phase I Cyclophosphamid Pazopanib Dose level I 50 mg/day 400 mg/day Dose level II 50 mg/day 600 mg/day Dose level III 50 mg/day 800 mg/day

    Cyclophosphamide 50 mg daily orally Pazopanib 400, 600 or 800 mg daily orally

    Phase II:

    Cyclophosphamide 50 mg daily orally Pazopanib 400, 600 or 800 mg daily orally The dose for the phase II part of the trial will be based on the MTD of phase I.

Study groups in NCT01238770
Study groupRoleWhat they receive
Cyclophosphamid + PazopanibExperimentalCyclophosphamid + Pazopanib
Receives: Drug: Pazopanib

What is being measured

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

  1. Determination of the optimal doses for pazopanib (phase I)

    Measured: 42 months

  2. Overall response rate according to RECIST criteria / clinical benefit (stable disease or partial response or complete response) (phase II)

    Measured: 12 weeks after start of treatment

Secondary outcomes (5)

  1. Time to progression (TTP) according to RECIST criteria

    Measured: 7 years

  2. Overall survival

    Measured: 7 years

  3. Evaluation of CA125 tumour response

    Measured: 7 years

  4. Number of patients with Adverse Events

    Measured: 7 years

  5. Assessment of quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire

    Measured: 7 years

Timeline

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

  1. First posted11 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionOct 2014
  4. Study completionOct 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01238770
Sponsor's protocol ID
3107000
Status last verified
Feb 2016
First submitted
10 Nov 2010
Last updated
10 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Dinkic C, Eichbaum M, Schmidt M, Grischke EM, Gebauer G, Fricke HC, Lenz F, Wallwiener M, Marme F, Schneeweiss A, Sohn C, Rom J. Pazopanib (GW786034) and cyclophosphamide in patients with platinum-resistant, recurrent, pre-treated ovarian cancer - Results of the PACOVAR-trial. Gynecol Oncol. 2017 Aug;146(2):279-284. doi: 10.1016/j.ygyno.2017.05.013. Epub 2017 May 19.

    PubMed 28528917

  • Eichbaum M, Mayer C, Eickhoff R, Bischofs E, Gebauer G, Fehm T, Lenz F, Fricke HC, Solomayer E, Fersis N, Schmidt M, Wallwiener M, Schneeweiss A, Sohn C. The PACOVAR-trial: a phase I/II study of pazopanib (GW786034) and cyclophosphamide in patients with platinum-resistant recurrent, pre-treated ovarian cancer. BMC Cancer. 2011 Oct 20;11:453. doi: 10.1186/1471-2407-11-453.

    PubMed 22014006

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pazopanib in people with Epithelial Ovarian Cancer, run by Priv.-Doz. Dr. med. Joachim Rom at 5 sites in Germany.

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 11 inclusion and 33 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 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. 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?

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?

Determination of the optimal doses for pazopanib (phase I) (time frame: 42 months). The study lists 2 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 NCT01238770, 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 10 Feb 2016.

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