New pill could tame rare, aggressive tumors without surgery
NCT ID NCT01876082
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial tested the drug pazopanib against a standard chemotherapy combination (vinblastine and methotrexate) in 72 adults with progressive desmoid tumors. Desmoid tumors are non-cancerous but can grow aggressively and come back after surgery. The study measured how many patients stayed alive and tumor-free at 6 months. Pazopanib is a daily pill that blocks blood vessel growth, while the comparison treatment is given by injection. The goal is to find a less invasive way to control these tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pazopanib (a targeted cancer drug taken as a pill)
- What this could lead to
- If it works, pazopanib could offer a new, pill-based option to control desmoid tumors without surgery or stronger chemotherapy.
- What could go wrong
- This is a phase 2 trial with only 72 people, so results are preliminary. Pazopanib may not work better than existing treatments and can cause side effects like fatigue, high blood pressure, and liver issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
72 people
The number who actually took part.
- Started
-
Sep 2012
- Finished
-
Sep 2019
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written consent; 2. Age ≥ 18 years; 3. ECOG ≤ 1; 4. Histologically confirmed desmoid tumor; 5. Disease progression before the patient's inclusion : completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted) 6. Measurable target lesion (RECIST criteria) ; 7. Left ventricular ejection fraction (MUGA or ECHO) within the normal; 8. Normal hematological, renal and liver functions : 1. Hemoglobin ≥ 9 g / dl; neutrophils ≥ 1.5 x 109 / l; platelets ≥ 100 x 109 / l; prothrombin time or INR1 ≤ 1.2 ULN or activated partial thromboplastin time ≤ 1.2 ULN; 2. Amino alanine transferase and aspartate amino transferase ≤ 2.5 ULN; 3. Total bilirubin ≤ 1.5 ULN; 4. Creatinine ≤ 1.5 mg/dl or, if creatinine\> 1.5 mg/dl, Creatinine clearance ≥ 50 m/min; 5. Urinary protein / urinary creatinine (Pu / Cu) \<1. If PU/Cu ≥ 1, patients must have a proteinuria below 1g/24 h 9. Women are eligible provided they: 1. Physiologically incapable of childbearing (hysterectomy, oophorectomy, bilateral tubal ligation, menopause). 2. Of childbearing age if they have had a negative pregnancy test in the week before the first dose of treatment. 3. Women of childbearing potential and men must agree to take an adequate method of contraception. Permitted contraceptive methods : IUD with a documented failure rate of 1% per year, Partner's vasectomy, complete sex abstinence (for 14 days before inclusion, the test period and after cessation of treatment according to the chemotherapy as described below), dual contraception, oral contraceptives. Effective contraception must be implemented: * Up to 6 months after treatment with vinblastine * Up to 5 months after treatment with Methotrexate for men and up to 3 months after treatment with Methotrexate for women * For the duration of treatment with Pazopanib; 10. Affiliated to a social security system Exclusion Criteria: 1. Personal history of malignancy except: 1. Cervical intraepithelial neoplasia; 2. Skin basal cell carcinoma; 3. Treated localized prostate carcinoma with PSA \<1; 4. Neoplasia treated with curative intent, in remission for at least five years and considered at low risk of relapse. 2. Pretreatement by Pazopanib or Methotrexate - vinblastine; 3. Known allergy to Pazopanib, Methotrexate or vinblastine; 4. Histological sampling not available for review or biological study; 5. Clinical abnormalities which may increase the risk of gastric bleeding (not exhaustive list); 1. Gastric tumor with known risk of bleeding; 2. Inflammatory bowel disease or other gastrointestinal disease may increase the risk of gastric perforation. 6. Pathologies that can lead to impaired intestinal absorption (not exhaustive): 1. Malabsorption; 2. Major resection of small intestine or stomach. 7. Active uncontrolled infectious disease; 8. Corrected QT interval\> 480 ms; 9. History of cardiovascular disease in the last 6 months: 1. Cardiac angioplasty; 2. Myocardial infarction; 3. Unstable angina; 4. Bypass surgery; 5. Symptomatic arterial disease. 10. Congestive heart failure grade II, III or IV according to the New York Hearth Association (NYHA) classification; 11. Uncontrolled arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); 12. History of stroke or transient ischemic attack, pulmonary embolism or deep vein thrombosis not treated, within 6 months; 13. History of major surgery or trauma within 28 days prior the first day of treatment, or presence of a wound, fracture or non-healed ulcer; 14. Evidence of active bleeding or bleeding tendency; 15. Known endobronchial lesions and / or infiltrative lesions of the large vessels lung; 16. History of hemoptysis of more than 2.5 ml in the eight weeks preceding the first day of chemotherapy; 17. Pulmonary dysfunction, asthma, emphysema, chronic obstructive pulmonary bronchitis, pneumonia, pneumothorax, pulmonary contusion, hemothorax, distress acute respiratory syndrome, pulmonary fibrosis; 18. Severe renal dysfunction; 19. Severe hepatic dysfunction; 20. History of psoriasis, rheumatoid arthritis, alcoholism, illness or chronic liver dysfunction; 21. Any pre-existing severe or unstable medical or psychiatric condition, or other condition that may interfere with patient safety, the collection of its informed consent or adherence to treatment; 22. Patient who refused or could not stop taking banned drugs for at least 14 days (or 5 half-lives of the drug) before the first day of start of chemotherapy and for the duration of the study; 23. During cancer treatment: 1. Radiotherapy, surgery or tumor embolization within 14 days before the 1st dose of pazobanib (arm A) or chemotherapy methotrexate, vinblastine (arm B); 2. Chemotherapy, immunotherapy, biological treatment, experimental or hormone therapy within 14 days or 5 half-lives of medication before the first day of the pazopanib (arm A) or chemotherapy with methotrexate, vinblastine (arm B). 24. History of cancer treatment toxicity\> grade 1 and / or whose the intensity increases, outside of alopecia. 25. Pregnancy and lactation 26. Concomitant treatment which can't be interrupted or replaced and which is not indicated with methotrexate: 1. Probenecid (alone or associated with sulfamethoxazole), 2. Trimethoprim, 3. Acetylsalicylic acid (for methotrexate doses above 20 mg per week with the acetylsalicylic acid and used at doses analgesics or antipyretics (≥ 500 mg per dose and/or \<3 g per day)or anti-inflammatory (≥ 1 g per dose and / or \> 3 g per day), 4. Phenylbutazone, 5. Yellow fever vaccine.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Progressive desmoids tumors are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institut Bergonié
Bordeaux, Aquitaine, 33000, France