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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01238770
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : February 10, 2016
Information provided by (Responsible Party):
Priv.-Doz. Dr. med. Joachim Rom, University Hospital Heidelberg

Brief 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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Drug: Pazopanib Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Pazopanib (GW786034) and Cyclophosphamide in Patients With Platinum-resistant Recurrent, Pre-treated Ovarian Cancer
Study Start Date : November 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: Cyclophosphamid + Pazopanib
Cyclophosphamid + Pazopanib
Drug: Pazopanib

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.

Other Name: Cyclophosphamid

Primary Outcome Measures :
  1. Determination of the optimal doses for pazopanib (phase I) [ Time Frame: 42 months ]
  2. Overall response rate according to RECIST criteria / clinical benefit (stable disease or partial response or complete response) (phase II) [ Time Frame: 12 weeks after start of treatment ]

Secondary Outcome Measures :
  1. Time to progression (TTP) according to RECIST criteria [ Time Frame: 7 years ]
  2. Overall survival [ Time Frame: 7 years ]
  3. Evaluation of CA125 tumour response [ Time Frame: 7 years ]
  4. Number of patients with Adverse Events [ Time Frame: 7 years ]
  5. Assessment of quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire [ Time Frame: 7 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. 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.
  3. Clinically significant gastrointestinal abnormalities which might interfere with oral dosing
  4. Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
  5. Prolongation of corrected QT interval (QTc) >480 msecs.
  6. History of any one or more of the following cardiovascular conditions within the past 6 months:

    • 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
  7. Macroscopic hematuria
  8. Hemoptysis that is clinically relevant within 4 weeks of first dose of study drug
  9. Evidence of active bleeding or bleeding diathesis
  10. Known endobronchial lesions or involvement of large pulmonary vessels by tumor
  11. 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.
  12. Chemotherapy or radiation therapy within 2 weeks prior to the first dose of study drug.
  13. Biological therapy, hormonal therapy or treatment with an investigational agent within 28 days or 5 half-lives
  14. Prior antiangiogenic therapy.
  15. 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
  16. Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity.
  17. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
  18. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  19. Pregnancy
  20. More than 3 different chemotherapy regimens in advanced tumor setting
  21. Uncontrolled hypertension
  22. History of ischemic event (stroke, myocardial infarction, unstable angina, TIA, symptomatic peripheral vascular disease)
  23. History or clinical evidence of thrombo-embolic event
  24. History of haemoptysis, cerebral, or clinically significant gastrointestinal haemorrhage in the past 6 months
  25. Active bleeding
  26. Signs/Suspicion of intestinal obstruction

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 identifier (NCT number): NCT01238770

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Marienkrankenhaus Hamburg
Hamburg, Germany, 22087
Heidelberg, Germany, 69120
Klinikum Konstanz Gynäkologie und Geburtshilfe
Konstanz, Germany, 78464
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik und Poliklinik für Geburtshilfe und Frauenheilkunde
Mainz, Germany, 55131
Universitätsfrauenklinik Tübingen Klinik für Gynäkologie und Geburtshilfe
Tübingen, Germany, 72076
Sponsors and Collaborators
Priv.-Doz. Dr. med. Joachim Rom
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Principal Investigator: Michael Eichbaum, PD Dr. med. Medizinische Fakultät Heidelberg Abteilung für Frauenheilkunde und Geburtshilfe
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Priv.-Doz. Dr. med. Joachim Rom, PD Dr. med, University Hospital Heidelberg Identifier: NCT01238770    
Other Study ID Numbers: 3107000
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Keywords provided by Priv.-Doz. Dr. med. Joachim Rom, University Hospital Heidelberg:
Ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists