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Adrenocortical CarcinomaPhase 2PAXONCT00786110

Sorafenib Plus Paclitaxel in Adreno-Cortical-Cancer Patients

A Phase 2 study testing Sorafenib and Paclitaxel in people with Adrenocortical Carcinoma, run by University of Turin, Italy at 5 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study is designed as a Phase II, prospective, non randomized, open-label, single arm, multicenter trial, in which patients with locally advanced or metastatic ACC not amenable to complete surgical resection and progressing to cytotoxic chemotherapy will receive Sorafenib plus metronomic chemotherapy as… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Adrenocortical Carcinoma
What is being tested?
Sorafenib and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesItaly
Study dates
Apr 2008to Oct 2010
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of ACC
  • Locally advanced or metastatic disease not amenable to radical surgery resection
  • Radiologically monitorable disease
  • Progressing disease after one or two cytotoxic chemotherapy regimens (including a platin-based protocol)
  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
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  • Subjects with at least one uni-dimensional(for RECIST) or bi-dimensional(for WHO) measurable lesion. Lesions must be measured by CT-scan or MRI
  • Age ≥ 18 years
  • Adequate bone marrow reserve (neutrophils ≥ 1500/mm³ and platelets ≥ 80.000/mm³)
  • Hemoglobin > 9.0 g/dl
  • Total bilirubin < 1.5 times the upper limit of normal
  • PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
  • Serum creatinine < 1.5 x upper limit of normal
  • Effective contraception in pre-menopausal female and male patients
  • Patient´s written informed consent
  • Ability to comply with the protocol procedures

Who cannot join

  • History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
  • History of HIV infection or chronic hepatitis B or C (This criteria should be modified to allow Hepatitis B or C in protocols looking at HCC patient population)
  • Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  • Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
  • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
  • History of organ allograft The organ allograft may be allowed as protocol specific
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  • Severe renal (serum creatinine > 2.5 x ULN) or hepatic insufficiency (ALT / - AST > 2.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN)
  • Concomitant Rifampicin
  • Concomitant St. John's Wort (Hypericum perforatum)
  • Warfarin is allowed; however, close monitoring of Prothrombin Time (PT) is recommended
  • Decompensated heart failure (ejection fraction <45%), myocardial infarction or revascularization procedure during the last 6 months, unstable angina pectoris, uncontrolled cardiac arrhythmia
  • Hypertension that cannot be controlled by medications (>160/100 mmHg despite optimal medical therapy)
  • Patients with recent or active bleeding diathesis
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment.
  • Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and three months after the completion of trial
  • Previous treatment with Sorafenib or other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry
  • Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).
  • Major surgery within 4 weeks of start of study
  • Autologous bone marrow transplant or stem cell rescue within 4 months of study
  • Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
  • Current treatment with another investigational drug
  • Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

5 sites in 1 country.

Fulvia Daffara contact

+390119026 ext. Ext. 992

fulviaclaudia@libero.it

Sperone Sperone contact

+390119026 ext. Ext. 017

paola.sperone@email.it

5 sites in 1 country

Italy5 sites, 5 recruiting

  • Department of Clinical and Biological Sciences, University of Turin

    Orbassano

    Paola Perotti, : +390119026 ext. Ext. 017

    Alfredo Berruti

    Recruiting

  • Azienda Ospedaliera di Padova

    Padova

    Franco Mantero

    Franco Mantero

    Not yet recruiting

  • Azienda Ospedaliera Università di Palermo

    Palermo

    Vittorio Gebbia

    Not yet recruiting

  • Policlinico Universitario Campus Biomedico- Roma

    Roma

    Daniele Santini

    Daniele Santini

    Not yet recruiting

  • Ist. Clin.Humanitas

    Rozzano

    Carlo Carnaghi

    Carlo Carnaghi

    Not yet recruiting

Other trials in Italy

About this study

Official title: Sorafenib Plus Paclitaxel Metronomic Chemotherapy in Adreno-Cortical-Carcinoma Patients Progressing After 1st or 2nd Line Cytotoxic Chemotherapy

The study is designed as a Phase II, prospective, non randomized, open-label, single arm, multicenter trial, in which patients with locally advanced or metastatic ACC not amenable to complete surgical resection and progressing to cytotoxic chemotherapy will receive Sorafenib plus metronomic chemotherapy as treatment.The aim of this phase II trial is to evaluate the clinical benefit and toxicity of the combination of Sorafenib plus metronomic chemotherapy in patients with locally advanced or metastatic ACC who progressed after first or second line chemotherapy.

Read the detailed description

The study is designed as a Phase II, prospective, non randomized, open-label, single arm, multicenter trial, in which patients with locally advanced or metastatic ACC not amenable to complete surgical resection.

STUDY OBJECTIVES

The aim of this phase II trial is to evaluate the clinical benefit and toxicity of the combination of Sorafenib plus metronomic chemotherapy in patients with locally advanced or metastatic ACC who progressed after first or second line chemotherapy.

Primary objective

To assess the clinical benefit as measured by a non progressing rate after 4 months of the combination of Sorafenib plus weekly Paclitaxel in patients with locally advanced or metastatic ACC who progressed after first or second line chemotherapy.

Secondary objectives

  • Assessment of Objective (Complete and Partial) Response Rates
  • Assessment of Duration of Response
  • Assessment of Hormonal Response
  • Assessment of Progression-Free Survival
  • Assessment of Overall Survival
  • Assessment of the relationship between specific "biomarkers" and cancer- and treatment-related outcomes
  • Assessment of Quality of Life by EORTC QLQ-C30
  • Assessment of Toxicity

ENDPOINTS

The first disease assessment will be performed after 8-weeks, subsequent assessments will be performed every 12 weeks until end of the study.

Primary endpoint

  • Progression-Free Survival rate ≥ 40% after 4 months

Secondary endpoints

  • Response rate evaluation will be performed according to the RECIST criteria. The same methods of measurement and the same technique should be used to characterize each identified and reported lesion at baseline and during study.

TREATMENT SCHEME Treatment scheme consisted of oral Sorafenib 400 mg p.o. bid plus intravenous Paclitaxel 60 mg/mq/weekly i.v., until disease progression.

Being tested
Sorafenib, Paclitaxel
Keywords
Sorafenib, Paclitaxel, Disease free survival
Medical subject headings
Adrenocortical Carcinoma

What participants receive

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

  • SorafenibDrug

    Treatment scheme consisted of oral Sorafenib 400 mg p.o. bid until disease progression.

  • PaclitaxelDrug

    Intravenous Paclitaxel 60 mg/mq/weekly i.v., until disease progression.

Study groups in NCT00786110
Study groupRoleWhat they receive
1 arm onlyExperimentalOne arm only with Sorafenib plus Paclitaxel Patients enrolled will undergo strict follow-up Intervention: Sorafenib plus Paclitaxel
Receives: Drug: Sorafenib; Drug: Paclitaxel

What is being measured

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

  1. Disease free survival

    Measured: 4 months

Secondary outcomes (1)

  1. Overall survival

    Measured: 4 months

Timeline

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

  1. First posted6 Nov 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionOct 2009 (estimated)
  4. Study completionOct 2010 (estimated)

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00786110
Sponsor's protocol ID
EudraCT 2008-000759-91
Acronym
PAXO
Status last verified
Feb 2009
First submitted
5 Nov 2008
Last updated
24 Feb 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Terzolo M, Angeli A, Fassnacht M, Daffara F, Tauchmanova L, Conton PA, Rossetto R, Buci L, Sperone P, Grossrubatscher E, Reimondo G, Bollito E, Papotti M, Saeger W, Hahner S, Koschker AC, Arvat E, Ambrosi B, Loli P, Lombardi G, Mannelli M, Bruzzi P, Mantero F, Allolio B, Dogliotti L, Berruti A. Adjuvant mitotane treatment for adrenocortical carcinoma. N Engl J Med. 2007 Jun 7;356(23):2372-80. doi: 10.1056/NEJMoa063360.

    PubMed 17554118

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib and Paclitaxel in people with Adrenocortical Carcinoma, run by University of Turin, Italy at 5 sites in Italy.

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 16 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 24 Feb 2009. 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 Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fulvia Daffara (+390119026 ext. Ext. 992, fulviaclaudia@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (time frame: 4 months). 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 NCT00786110, which also lists 1 linked publication.

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 24 Feb 2009.

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