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A Phase I/II Study of Pazopanib (GW786034) and Cyclophosphamide in Patients With Platinum-resistant Recurrent, Pre-treated Ovarian Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Epithelial Ovarian Cancer, Which is Platinum Resistant or Refractory, Cancer of the Fallopian Tube or Peritoneal Cancer

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Trial Information

A Phase I/II Study of Pazopanib (GW786034) and Cyclophosphamide in Patients With Platinum-resistant Recurrent, Pre-treated Ovarian Cancer

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.

Inclusion Criteria:

1. 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
assessments and procedures.

2. Female subjects ≥18 years of age

3. Histologically or cytologically confirmed diagnosis of: epithelial ovarian cancer
which is platinum resistant (relapse-free interval < 6 months of a
platinum-containing primary or secondary platinum therapy) or platinum refractory
(progressive disease during primary or secondary platinum therapy), cancer of the
fallopian tube, peritoneal cancer Definition of relapse: Demonstration of measurable
or non-measurable tumour according to RECIST criteria by an imaging procedure (where
applicable before relapse surgery) or increase in the tumour marker CA-125 to twice
the upper laboratory value of normal for the hospital

4. Patients must have failed available standard chemotherapy regimen (except if
medically contraindicated or refused by the patient)

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. A life expectancy of at least 12 weeks.

Exclusion Criteria:

1. Diagnosis of 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. Screening
with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging
[MRI]) is required only if clinically indicated or if the subject has a history of
CNS metastases.

3. Clinically significant gastrointestinal abnormalities which might interfere with oral

- Active peptic ulcer disease

- Known intraluminal metastatic lesion/s with suspected bleeding

- Inflammatory bowel disease

- Ulcerative colitis, or other gastrointestinal conditions with increased risk of

- History of abdominal fistula, gastrointestinal perforation, or intra abdominal
abscess within 28 days prior to beginning study treatment

- Malabsorption syndrome

- Major resection of the stomach or small bowel

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 Note: Subjects with recent DVT who
have been treated with therapeutic anti-coagulant agents (excluding therapeutic
warfarin) for at least 6 weeks are eligible

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

13. Biological therapy, hormonal therapy or treatment with an investigational agent
within 28 days or 5 half-lives, whichever is longer prior to the first dose of study

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 (for women of childbearing potential absence to be confirmed by ß-hCG test)
or lactation period or missing contraception of women of childbearing potential
(Pearl-Index < 1, e.g. hormonal contraception including the combined oral
contraceptive pill, the transdermal patch, and the contraceptive vaginal ring,
intrauterine devices or sterilization) during treatment and for at least 6 months

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the optimal doses for pazopanib (phase I)

Outcome Time Frame:

Phase I during treatment

Safety Issue:


Principal Investigator

Michael Eichbaum, PD Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medizinische Fakultät Heidelberg Abteilung für Frauenheilkunde und Geburtshilfe


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

November 2010

Completion Date:

March 2015

Related Keywords:

  • Epithelial Ovarian Cancer, Which is Platinum Resistant or Refractory, Cancer of the Fallopian Tube or Peritoneal Cancer
  • Ovarian cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial