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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

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Trial Conditions
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given alone or together with vandetanib. PURPOSE: This randomized phase II trial is studying docetaxel given together with or without vandetanib to see how well it works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Female

Eligibility

DISEASE CHARACTERISTICS:

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

- 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
regimen

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

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Absolute neutrophil count (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)

- aspartate aminotransferase - alanine aminotransferase (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 New York Heart Association
(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

- QT interval 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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

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

- No prior vandetanib

- Treatment with other anti-vascular endothelial growth factor (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 cytochrome P450
3A4 (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
biopsy

- 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
cancer

- 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

Gender: Female
Steward Physician(s)
  • Robert L. Coleman, MD
Facilities
  • Holy Family Hospital - Active, not recruiting
Trial Interventions
Drug
  • docetaxel
  • vandetanib
Physician Researcher

Investigator Name:

  • Robert L. Coleman, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00872989
Volunteers:  Not Accepting Healthy Volunteers

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