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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
N/A
Open (Enrolling)
Female
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


OBJECTIVES:

- 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


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

- 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

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-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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Robert L. Coleman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000638595

NCT ID:

NCT00872989

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - WichitaWichita, Kansas  67214-3882
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - DaytonKettering, Ohio  45429
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
University of California Davis Cancer CenterSacramento, California  95817
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Peninsula Medical CenterBurlingame, California  94010
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
California Pacific Medical Center - California CampusSan Francisco, California  94118
Sutter Solano Medical CenterVallejo, California  94589
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Mecosta County Medical CenterBig Rapids, Michigan  49307
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Highland Hospital of RochesterRochester, New York  14620
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
Highland General HospitalOakland, California  94602
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Wayne HospitalGreenville, Ohio  45331
Clinton Memorial HospitalWilmington, Ohio  45177
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Harrison Poulsbo Hematology and OnocologyPoulsbo, Washington  98370
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Pardee Memorial HospitalHendersonville, North Carolina  28791
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Midwest Hematology Oncology Group, IncorporatedSaint Louis, Missouri  63109
Providence Cancer Center at Providence HospitalMobile, Alabama  36608
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Tibotec Therapeutics - Division of Ortho Biotech Products, LPMarysville, California  95901
El Camino Hospital Cancer CenterMountain View, California  94040
Tahoe Forest Cancer CenterTruckee, California  96161
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
Hawaii Medical Center - EastHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
Maui Memorial Medical CenterWailuku, Hawaii  96793
Mercy General Health PartnersMuskegon, Michigan  49443
United States Air Force Medical Center - Wright-PattersonWright-Patterson AFB, Ohio  45433-5529
U.T. Medical Center Cancer InstituteKnoxville, Tennessee  37920-6999
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Caritas Holy Family HospitalMethuen, Massachusetts  01844
Falck Cancer Center at Arnot Ogden Medical CenterElmira, New York  14905
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California  91505
Shaw Regional Cancer CenterEdwards, Colorado  81632
San Luis Valley Regional Medical CenterAlamosa, Colorado  81101
Valley View Hospital Cancer CenterGlenwood Springs, Colorado  81601
Castle Medical CenterKailua, Hawaii  96734
Kauai Medical ClinicLihue, Hawaii  96766
Central Dupage Cancer CenterWarrenville, Illinois  60555
NEA Medical Center - Stadium BoulevardJonesboro, Arkansas  72401