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Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer (TAPAZ)

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ClinicalTrials.gov Identifier: NCT02383251
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : February 24, 2022
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

Brief Summary:
Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Pazopanib Drug: Paclitaxel Phase 2

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Pazopanib and Weekly Paclitaxel in Patients With Platinum Resistant/Refractory Ovarian Cancer Who Relapse During Bevacizumab Maintenance
Actual Study Start Date : June 15, 2015
Actual Primary Completion Date : August 2019
Actual Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Pazopanib/Paclitaxel association

Arm 1 :

Pazopanib alone during 1 week at 600 mg (1x400mg and 1x200mg), per day, taken orally without food at least one hour before or two hours after a meal.

Then:

  • Pazopanib 600 mg (1x400mg and 1x200mg), per day, taken orally without food at least one hour before or two hours after a meal.
  • Paclitaxel 65 mg/m2 i.v. on days 1, 8, 15 every 28 days until progression of disease or toxicity
Drug: Pazopanib
Pazopanib 600mg during the fist cycle. Then, if there is not heptic triuyble, the dose could be increased to 800mg
Other Name: Votrient

Drug: Paclitaxel
Arm 1 : Paclitaxel 65mg/m² Arm 2: Paclitaxel 80mg/m²
Other Name: Taxol

Active Comparator: Paclitaxel alone

Arm 2 :

  • Paclitaxel 80mg/m2 i.v. on days 1, 8, 15
  • every 28 days until progression of disease or toxicity
Drug: Paclitaxel
Arm 1 : Paclitaxel 65mg/m² Arm 2: Paclitaxel 80mg/m²
Other Name: Taxol




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 4 months ]
    Proportion of progression or death 4 months after initiation of treatment


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 2 years ]
    Time between randomization and death or last news date for patient alive at the last visit date

  2. Disease control rate (DCR) [ Time Frame: Up to 2 years ]
    Proportion of woman in partial, compete or stable desease according to RECIST 1.1. criteria

  3. Toxicity according to NCI CTCAE v4.3 criteria [ Time Frame: Up to 2 years ]
    tolerance of the treatment based on AE occurrence according to NCI CTCAE v4.3 criteria

  4. health-related quality of life [ Time Frame: Up to 2 years ]
    health-related quality of life and symptomatic state will be evaluated by filing questionnaires by patients



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Performance status ECOG < 2
  3. Histological documented ovarian, tubal or peritoneum carcinoma (stage IC to IV)
  4. Patient treated at least with one line of platinum-based chemotherapy who have relapsed within 6 months after trhe last administration of platinum-based chemotherapy and taking bevacizumab for maintenance NB: Penultimate line of chemotherapy could contain chemotherapy without platinum and the last line should contain platinum-based chemotherapy (followed by bevacizumab for maintenance)
  5. Patients must have disease that is measurable and/or evaluable according to RECIST criteria and requires chemotherapy treatment
  6. Patients with liver metastasis can be included
  7. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
  8. Life expectancy of more than 3 months
  9. Able to swallow and retain oral medication
  10. Adequate organ system function like:

Total bilirubin ≤ 1.5 X ULN Alanine amino transferase (ALT) and Aspartate aminotransferase (AST)c ≤ 2.5 X ULN

  1. Subjects may not have had a transfusion within 7 days of screening assessment.
  2. Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation.
  3. Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN (upper limit of normal) are not permitted.
  4. If UPC <1, then a 24-hour urine protein must be assessed. Subjects must have a 24-hour urine protein value <1 g to be eligible. Use of urine dipstick for renal function assessment is not acceptable. 10. Women of childbearing potential must agree to use effective contraception 11. Negative serum pregnancy test (if applicable) 12. Affiliated to or a beneficiary of a social security category

Exclusion Criteria:

  1. Prior malignancy over the past 5 years with the exception of in situ carcinomas of the cervix or basal and squamous cell carcinoma or nonmelanoma skin cancer properly treated, or all solid tumor, considered as in completed remission without relapse for at least 5 years
  2. Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery ± radiotherapy) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants of P3A4 cytochrom
  3. Previous treatment with monotherapy weekly paclitaxel
  4. Previous treatment with bevacizumab within three weeks before start of studt treatment
  5. Patients with severe hypersensitivity to a product containing castor oil polyoxyl 35 or paclitaxel solvent: the Chremophor
  6. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:

    • Active peptic ulcer disease
    • Known intraluminal metastatic lesion/s with risk of bleeding
    • Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn's disease), or other gastrointestinal conditions with increased risk of perforation
    • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
  7. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:

    • Malabsorption syndrome
    • Major resection of the stomach or small bowel.
  8. Corrected QT interval (QTc) > 450 msecs or > 480 msecs for patient with block branch
  9. History of any one or more of the following cardiovascular conditions within the past 6 months:

    • Cardiac angioplasty or stenting
    • Myocardial infarction
    • Unstable angina
    • Coronary artery bypass graft surgery
    • Symptomatic peripheral vascular disease
    • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
    • Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].
  10. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
  11. Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
  12. to 14: All risk of bleeding

15 Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. 16 Unable or unwilling to discontinue use of prohibited medications 17 Treatment with any of the following anti-cancer therapies:

  • radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib (out of bevacizumab) OR
  • chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib (out of bevacizumab) 18 Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment 19 Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia. 20 Patient deprived of liberty or state-controlled 21 Inability to participate to medical follow up for geographic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383251


Locations
Show Show 36 study locations
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Novartis
Investigators
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Principal Investigator: Florence JOLY, PHD Centre François Baclesse, Caen
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Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT02383251    
Other Study ID Numbers: GINECO-OV231
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action