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Randomized Phase II Study of Docetaxel Followed by Vandetanib (ZD6474) vs. Docetaxel Plus Vandetanib in Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Phase 2
18 Years
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

Randomized Phase II Study of Docetaxel Followed by Vandetanib (ZD6474) vs. Docetaxel Plus Vandetanib in Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


- To evaluate the clinical efficacy of docetaxel and vandetanib relative to docetaxel
alone in patients with platinum-resistant, recurrent, refractory, or
progressive/persistent ovarian epithelial, primary peritoneal, or fallopian tube
cancer, as measured by progression-free survival.

- To evaluate the response rate (complete and partial) and duration of overall survival
of these patients.

- To evaluate the response (complete and partial) and time to treatment failure after
treatment with single agent vandetanib following progression on single agent docetaxel.

- To evaluate the frequency and severity of adverse events as assessed by CTCAE v4.0.

- To evaluate the toxicity of single agent vandetanib following docetaxel as assessed by
CTCAE v4.0.

OUTLINE: Patients are stratified according to prior treatment with antiangiogenesis agents
(yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days
in the absence of disease progression or unacceptable toxicity. Patients who progress
also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in
the absence of a second disease progression or unacceptable toxicity.

- Arm II: Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once
daily on days 1-21. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria


- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal

- Recurrent, refractory, or progressive/persistent disease

- Measurable or non-measurable disease documented by CT scan of the abdomen and pelvis

- Must have received 1 prior platinum-based chemotherapy regimen for management of
primary disease containing carboplatin, cisplatin, or other organoplatinum compound

- Initial treatment may have included any of the following:

- High-dose therapy

- Consolidation therapy

- Non-cytotoxic agent therapy

- Extended therapy administered after surgical or non-surgical assessment

- Additional cytotoxic regimen for recurrent, refractory, or
progressive/persistent disease, including re-treatment with primary treatment

- No more than 3 prior regimens for recurrent, refractory, persistent, or progressive


- Zubrod performance status 0-2

- ANC ≥ 1,500/mcl

- Platelet count ≥ 100,000/mcl

- Serum creatinine normal OR calculated creatinine clearance ≥ 30 mL/min

- Urine protein:creatinine ratio < 1

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases are present)

- Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases are present)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of vandetanib therapy

- No neuropathy ≥ grade 2 CTCAE v4.0

- No active infection requiring systemic or intravenous antibiotics

- No significant traumatic injury within the past 28 days

- No significant cardiovascular disease, including any of the following:

- Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 140 mm Hg or
diastolic BP > 90 mm Hg) within the past 28 days

- Myocardial infarction superior vena cava syndrome, or NYHA class II-IV heart
disease within the past 3 months

- Presence of left bundle branch block

- Congenital long QT syndrome or first degree relative with unexplained sudden
death < 40 years of age

- QTc with Bazett's correction that is unmeasurable or ≥ 480 msec by screening ECG

- History of symptomatic arrhythmia (i.e., multifocal premature ventricular
contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled
atrial fibrillation) requiring treatment (≥ CTCAE grade 3) or asymptomatic
sustained ventricular tachycardia

- Atrial fibrillation controlled on medication allowed


- See Disease Characteristics

- Recovered from all prior therapy (except alopecia) to NCI CTCAE v3.0 grade ≤ 1

- No prior vandetanib

- Treatment with other anti-VEGF targeted therapy allowed

- No prior docetaxel or any non-cytotoxic therapy (excluding hormonal therapy) for
recurrent disease, regardless of whether it was part of primary treatment

- Prior docetaxel as part of front-line cytotoxic regimen (including maintenance
therapy) allowed as long as no disease progression on or within 6 months after
receiving docetaxel

- At least 7 days since prior hormonal therapy for the malignant tumor

- Concurrent hormone replacement therapy for menopausal symptoms allowed

- At least 28 days since other prior therapy for the malignant tumor, including
immunologic agents

- More than 7 days since prior minor surgical procedures, fine needle aspirates, or
core biopsies

- More than 14 days since prior and no concurrent potent inducers of CYP3A4 function

- More than 14 days since prior and no concurrent medications having a risk of causing
Torsades de Pointes or risk of QTc prolongation

- Patients receiving a drug that has a risk of QTc prolongation must not have QTc
≥ 460 msec

- More than 28 days since prior investigational agents for any purpose

- More than 28 days since prior and no concurrent major surgical procedure or open

- More than 5 years since prior chemotherapy for abdominal or pelvic tumor, except
treatment of ovarian, fallopian tube, or primary peritoneal cancer

- Prior adjuvant chemotherapy for localized breast cancer allowed, provided it was
completed more than 3 years prior to study, and the patient remains free of
recurrent or metastatic disease

- More than 5 years since prior radiotherapy to any portion of the abdominal cavity or
pelvis, except for the treatment of ovarian, fallopian tube, or primary peritoneal

- Prior radiotherapy for localized cancer of the breast, head and neck, or skin
allowed, provided it was completed more than 3 years prior to study, and the
patient remains free of recurrent or metastatic disease

- No prior radiation to more than 25% of marrow-bearing areas

- More than 28 days since prior radiotherapy

- No other concurrent investigational or commercial agents

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Robert L. Coleman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2010

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • recurrent fallopian tube cancer
  • recurrent primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



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