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Carcinoma, Non-Small-Cell LungPhase 2/3NCT00775307

Adjuvant Pazopanib in Stage I NSCLC

A Phase 2/3 study testing PAZOPANIB in people with Carcinoma, Non-Small-Cell Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 40 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T < or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
PAZOPANIB
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
40 sitesFrance
Study dates
Nov 2008to 18 Apr 2016
Phase
Phase 2/3
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

  • Complete resection of the primary tumour and local extension has to be performed. All margins must be free of microscopical disease. At the time of resection, a complete mediastinal lymph-node resection or lymph-node sampling is required. Surgeons are encouraged to dissect or sample all accessible nodal levels.
  • Single surgically resected pathological stage I NSCLC lesion: consisting of a tumor < 5 cm in greatest dimension (see TNM staging on Appendix 10).
  • No regional lymph node involvement.
  • Pre-operative petscan
  • Satisfactory healing of surgical wound.
  • Patients >= 18 and < 70 years of age.
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  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  • Recruited to the study and available to start treatment investigational product at least 4 weeks but no longer that 8 weeks after the surgical resection of the NSCLC.
  • No approved or investigational anti-cancer therapy concurrently or in the 5 years prior to start of study drug, including tumor embolization, chemotherapy, radiation therapy, immunotherapy, hormone therapy, biologic therapy, or anti angiogenic therapy (e.g., inhibitors of VEGF or VEGFR).
  • Adequate organ system function
  • Ability to swallow and retain oral medication.
  • 12. A female is eligible to enter and participate in this study if she is of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has undergone:
  • Hysterectomy.
  • Bilateral oophorectomy (ovariectomy).
  • Bilateral tubal ligation.
  • Or who is post-menopausal:
  • Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for ≥1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone value >40 mIU/mL and an estradiol value <40 pg/mL (<140 pmol/L).
  • Subject using HRT must have experienced total cessation of menses for ≥ 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT.
  • Childbearing potential, including any female who has had a negative serum pregnancy test within 1 week prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. Contraceptive methods acceptable to the IFCT, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
  • An intrauterine device with a documented failure rate of less than 1% per year.
  • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry and is the sole sexual partner for that female.
  • Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product.
  • Double-barrier contraception : condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
  • Oral contraceptive, either combined or progestogen alone [Hatcher, 2004]
  • Injectable progestogen [Hatcher, 2004]
  • Implant of levonorgestrel [Hatcher, 2004]
  • Estrogenic vaginal ring [Hatcher, 2004]
  • Percutaneous contraceptive patches [Hatcher, 2004]
  • Female patients who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 15 days following the last dose of study drug.
  • A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study.
  • French Patients: in France, a patient will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security insurance.

Who cannot join

  • Prior malignancy. Note: Patients who have had another malignancy and were treated more than 5 years ago and have since been considered cured, or patients with a history of basocellular skin carcinoma or in situ carcinoma of the uterine cervix are eligible.
  • Presence of any concurrent disease or condition that would make the subject inappropriate for study participation including any unresolved or unstable, serious toxicity from prior administration of another investigational drug or any serious medical disorder that would interfere with the subject's safety, obtaining informed consent, or compliance with all study related procedures.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study.
  • History or clinical evidence of nodal or distant metastases (screening of brain metastasis is mandatory).
  • Bronchioalveolar carcinoma of lobar or multi lobar involvement. Bronchioalveolar carcinomas presenting as a discrete solitary radiological mass or nodule are eligible.
  • History of human immunodeficiency virus infection or chronic hepatitis B or C.
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  • History of hemoptysis after resection of lung cancer.
  • Clinically significant gastrointestinal anomalies including, but not limited to:
  • Malabsorption syndrome
  • Disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect the absorption of study drug.
  • Active peptic ulcer disease
  • Inflammatory bowel disease
  • Ulcerative colitis, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis or other gastrointestinal condition increasing the risk of perforation.
  • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
  • Presence of active or uncontrolled infection.
  • Evidence of active bleeding or bleeding diathesis.
  • History of any one or more of the following cardiovascular conditions within the past 6 months:
  • Coronary/peripheral artery bypass graft, cardiac angioplasty or stenting.
  • Myocardial infarction.
  • Severe/unstable angina pectoris.
  • Symptomatic peripheral vascular disease, pulmonary embolism or untreated deep venous thrombosis (DVT), cerebrovascular accident or transient ischemic attack.
  • Note : Subject with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (Appendix 5).
  • Poorly controlled hypertension (defined as a systolic blood pressure (SBP) of >= 140 mmHg or diastolic blood pressure (DBP) >= 90 mmHg.
  • Note: Initiation or adjustment of anti-hypertensive medication(s) is permitted prior to study entry. Blood pressure (BP) must be re-assessed on two occasions separated by at least 5 minutes. The mean SBP/DBP values from both BP assessments must be <140/90 mmHg in order for a subject to be eligible for the study.
  • Following anomalies on ECG : Q wave, ischemia, QT > 480 msec, atrio-ventricular block 2 or 3, atrial fibrillation
  • Therapeutic anticoagulation treatment.
  • Chronic daily treatment with aspirin (≥ 325 mg/day) or non-steroidal anti-inflammatory agents known to inhibit platelet function. Treatment with dipyridamole, ticlopidine, clopidogrel and/or cilostazol is also not allowed.
  • Pregnant or lactating female.
  • Concurrent treatment with an investigational agent or participation in another clinical trial.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

France40 sites

  • Annemasse - CH

    Ambilly, 74100

  • Béziers - CH

    Béziers, 34525

  • Bobigny - Hôpital Avicenne

    Bobigny, 93000

  • Bordeaux - Polyclinique Nord

    Bordeaux, 33300

  • Boulogne - Ambroise Paré

    Boulogne

  • Caen - Centre François Baclesse

    Caen, 14000

  • Caen - CHU Côte de Nacre

    Caen, 14000

  • Clamart - Hôpital Percy

    Clamart, 92140

  • Clermont Ferrand - CHU

    Clermont-Ferrand, 63000

  • Colmar - CH

    Colmar, 68000

  • Dax - CH

    Dax, 40107

  • Grenoble - CHU

    Grenoble, 38000

  • Le Mans - Centre Hospitalier

    Le Mans, 72000

  • Lille - Hôpital Calmette

    Lille, 59000

  • Mantes La Jolie - CH

    Mantes-la-Jolie, 78200

  • Marseille - Hôpital Sainte Marguerite

    Marseille, 13000

  • Metz - Clinique Claude Bernard

    Metz, 57000

  • Mont de Marsan - CH

    Mont-de-Marsan, 40000

  • Montpellier - Clinique Clémentville

    Montpellier, 34070

  • Montpellier - CHRU

    Montpellier, 34295

  • Moulins - CH

    Moulins, 03000

  • Nantes - Centre René Gauducheau

    Nantes, 44805

  • Nevers - CH

    Nevers, 58033

  • CHU

    Nîmes

  • Orléans - CH

    Orléans, 45000

  • Paris - Saint Louis

    Paris, 75000

  • Paris - hôpital Saint-Antoine

    Paris, 75012

  • Paris - Hopital Tenon

    Paris, 75020

  • Pau - CH

    Pau, 64046

  • Centre Catalan d'Onologie

    Perpignan, 66000

  • Lyon Sud

    Pierre-Bénite, 69495

  • Reims - CHU

    Reims, 51092

  • Rennes - CHU

    Rennes, 35033

  • Strasbourg - NHC

    Strasbourg, 63000

  • Thonon les bains - CH

    Thonon-les-Bains, 74200

  • Toulon - HIA

    Toulon, 83000

  • Toulouse - CHU Larrey

    Toulouse

  • Nancy - CHU

    Vandœuvre-lès-Nancy, 54500

  • Vesoul - CHI

    Vesoul, 70000

  • Villejuif - Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase II-III Multi-centre Study to Evaluate the Effect of Adjuvant Pazopanib (GW786034) Versus Placebo on Post-surgical Disease-free Survival in Patients With Stage I Non Small Cell Lung Cancer and Tumor Size Equal or Inferior to 5 cm.

The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T < or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC.

Read the detailed description

The study will be conducted in two phases as follows:

  • The Phase II component of the study will be a randomized, double-blind, placebo-controlled, multi-centre study performed in France only. After undergoing NSCLC resection, 140 patients will be randomized to receive either pazopanib 400 mg per day or placebo for 24 weeks.
  • The Phase III component of the study will be a randomized, double-blind, placebo-controlled, multi-centre study performed internationally. Patients who have completed the Phase II component of the study will be followed and included in the Phase III. Additional patients will also be recruited to a planned total of 355 patients per treatment arm. New patients will be randomized to receive either pazopanib 400 mg per day or placebo for 24 weeks.
Being tested
PAZOPANIB, Placebo
Keywords
Non-small cell lung cancer, Stage I, adjuvant therapy, Adjuvant Drug Therapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • PAZOPANIBDrug

    400 mg/day (24 weeks)

  • PlaceboDrug

    Placebo 400 mg/day (24 weeks)

Study groups in NCT00775307
Study groupRoleWhat they receive
BPlacebo comparatorPlacebo 400 mg/day (24 weeks)
Receives: Drug: Placebo
AExperimentalPazopanib 400 mg/day (24 weeks)
Receives: Drug: PAZOPANIB

What is being measured

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

  1. Phase II component of the study : Feasibility of regime ; Phase III component of the study : disease-free survival (DFS)

    Measured: month

Secondary outcomes (1)

  1. Overall survival (OS), Detailed assessment of compliance, Incidence and severity of AEs and other safety measures, Reporting profile of AEs of interest during long-term follow-up, Rates of loco-regional and distant recurrences, Quality of Life

    Measured: month

Timeline

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

  1. First posted20 Oct 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionDec 2015
  4. Study completion18 Apr 2016

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00775307
Sponsor's protocol ID
IFCT-0703
Other IDs
Eudract : 2008-004897-41
Status last verified
Sep 2019
First submitted
17 Oct 2008
Last updated
24 Sep 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Besse B, Mazieres J, Ribassin-Majed L, Barlesi F, Bennouna J, Gervais R, Moreau L, Berard H, Debieuvre D, Molinier O, Moro-Sibilot D, Souquet PJ, Jacquot S, Petit L, Lena H, Pignon JP, Lacas B, Morin F, Milleron B, Zalcman G, Soria JC; Intergroupe Francophone de Cancerologie Thoracique (IFCT). Pazopanib or placebo in completely resected stage I NSCLC patients: results of the phase II IFCT-0703 trial. Ann Oncol. 2017 May 1;28(5):1078-1083. doi: 10.1093/annonc/mdx070.

    PubMed 28327934

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PAZOPANIB in people with Carcinoma, Non-Small-Cell Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 40 sites in France.

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 32 inclusion and 31 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Phase II component of the study : Feasibility of regime ; Phase III component of the study : disease-free survival (DFS) (time frame: month). 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 NCT00775307, 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 Sep 2019.

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