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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 Center Seattle, Washington  98109
University of Chicago Cancer Research Center Chicago, Illinois  60637
CCOP - Wichita Wichita, Kansas  67214-3882
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Dayton Kettering, Ohio  45429
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
University of California Davis Cancer Center Sacramento, California  95817
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Alaska Regional Hospital Cancer Center Anchorage, Alaska  99508
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Munson Medical Center Traverse City, Michigan  49684
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
Tulane Cancer Center Office of Clinical Research Alexandria, Louisiana  71315-3198
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Peninsula Medical Center Burlingame, California  94010
Sutter Health - Western Division Cancer Research Group Greenbrae, California  94904
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
California Pacific Medical Center - California Campus San Francisco, California  94118
Sutter Solano Medical Center Vallejo, California  94589
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Mecosta County Medical Center Big Rapids, Michigan  49307
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Highland Hospital of Rochester Rochester, New York  14620
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Danville Regional Medical Center Danville, Virginia  24541
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Montrose Memorial Hospital Cancer Center Montrose, Colorado  81401
Highland General Hospital Oakland, California  94602
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
Reid Hospital & Health Care Services Richmond, Indiana  47374
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Wayne Hospital Greenville, Ohio  45331
Clinton Memorial Hospital Wilmington, Ohio  45177
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Harrison Poulsbo Hematology and Onocology Poulsbo, Washington  98370
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
Providence Cancer Center at Providence Hospital Mobile, Alabama  36608
Contra Costa Regional Medical Center Martinez, California  94553-3156
Tibotec Therapeutics - Division of Ortho Biotech Products, LP Marysville, California  95901
El Camino Hospital Cancer Center Mountain View, California  94040
Tahoe Forest Cancer Center Truckee, California  96161
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
Hawaii Medical Center - East Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Kuakini Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Lusitana Honolulu, Hawaii  96813
Maui Memorial Medical Center Wailuku, Hawaii  96793
Mercy General Health Partners Muskegon, Michigan  49443
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
U.T. Medical Center Cancer Institute Knoxville, Tennessee  37920-6999
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Caritas Holy Family Hospital Methuen, Massachusetts  01844
Falck Cancer Center at Arnot Ogden Medical Center Elmira, New York  14905
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center Burbank, California  91505
Shaw Regional Cancer Center Edwards, Colorado  81632
San Luis Valley Regional Medical Center Alamosa, Colorado  81101
Valley View Hospital Cancer Center Glenwood Springs, Colorado  81601
Castle Medical Center Kailua, Hawaii  96734
Kauai Medical Clinic Lihue, Hawaii  96766
Central Dupage Cancer Center Warrenville, Illinois  60555
NEA Medical Center - Stadium Boulevard Jonesboro, Arkansas  72401