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Fallopian Tube CancerPhase 2NCT00872989

S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

A Phase 2 study testing docetaxel and vandetanib in people with Fallopian Tube Cancer and Ovarian Cancer, run by SWOG Cancer Research Network at 137 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
What is being tested?
docetaxel and vandetanib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
137 sitesUnited States
Study dates
Mar 2010to May 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

137 sites in 1 country.

137 sites in 1 country

United States137 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • San Luis Valley Regional Medical Center

    Alamosa, Colorado, 81101

  • Tulane Cancer Center Office of Clinical Research

    Alexandria, Louisiana, 71315-3198

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, 94704

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Falck Cancer Center at Arnot Ogden Medical Center

    Elmira, New York, 14905

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Wayne Hospital

    Greenville, Ohio, 45331

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • Hawaii Medical Center - East

    Honolulu, Hawaii, 96817

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • NEA Medical Center - Stadium Boulevard

    Jonesboro, Arkansas, 72401

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • U.T. Medical Center Cancer Institute

    Knoxville, Tennessee, 37920-6999

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67905

  • Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP

    Marysville, California, 95901

  • Caritas Holy Family Hospital

    Methuen, Massachusetts, 01844

  • Tucker Center for Cancer Care at Orange Regional Medical Center

    Middletown, New York, 10940-4199

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Providence Cancer Center at Providence Hospital

    Mobile, Alabama, 36608

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • El Camino Hospital Cancer Center

    Mountain View, California, 94040

  • Mercy General Health Partners

    Muskegon, Michigan, 49443

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Harrison Poulsbo Hematology and Onocology

    Poulsbo, Washington, 98370

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • California Pacific Medical Center - California Campus

    San Francisco, California, 94118

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

  • Sutter Health - Western Division Cancer Research Group

    San Rafael, California, 94903

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology, PS

    Spokane, Washington, 99218

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Midwest Hematology Oncology Group, Incorporated

    St Louis, Missouri, 63109

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Tahoe Forest Cancer Center

    Truckee, California, 96161

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724-5024

  • Sutter Solano Medical Center

    Vallejo, California, 94589

  • Maui Memorial Medical Center

    Wailuku, Hawaii, 96793

  • Central Dupage Cancer Center

    Warrenville, Illinois, 60555

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • 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 - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • United States Air Force Medical Center - Wright-Patterson

    Wright-Patterson AFB, Ohio, 45433-5529

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

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 Common Toxicity Criteria for Adverse Effects (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.

Being tested
docetaxel, vandetanib
Keywords
recurrent ovarian epithelial cancer, recurrent fallopian tube cancer, recurrent primary peritoneal cavity cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • docetaxelDrug

    Given IV

  • vandetanibDrug

    Given orally

Study groups in NCT00872989
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Drug: docetaxel; Drug: vandetanib
Arm IIExperimentalPatients 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.
Receives: Drug: docetaxel; Drug: vandetanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.

    Measured: Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years

Secondary outcomes (5)

  1. Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses

    Measured: Disease assessment for responses were performed every 6 weeks for as long as the patient remained on protocol treatment, up to 5 years.

  2. Overall Survival

    From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

    Measured: every 3 months for two years and then every 6 months for 3 years

  3. Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

    Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Toxicity assessment was evaluated before each treatment cycle (21 days), up to 5 years.

  4. Time to Treatment Failure

    Time to treatment failure after treatment with single agent vandetanib following progression on single agent docetaxel. Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.

    Measured: Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.

  5. Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease After Treatment With Single Agent Vandetanib Following Progression on Single Agent Docetaxel

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses

    Measured: Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2009 (estimated)
  2. Study startMar 2010
  3. Primary completionOct 2013
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00872989
Sponsor's protocol ID
CDR0000638595
Other IDs
S0904, U10CA032102
Status last verified
Oct 2016
First submitted
31 Mar 2009
Last updated
19 Dec 2016
Data monitoring committee
Yes

Publications

  • Coleman RL, Moon J, Sood AK, Hu W, Delmore JE, Bonebrake AJ, Anderson GL, Chambers SK, Markman M. Randomised phase II study of docetaxel plus vandetanib versus docetaxel followed by vandetanib in patients with persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: SWOG S0904. Eur J Cancer. 2014 Jun;50(9):1638-48. doi: 10.1016/j.ejca.2014.03.005. Epub 2014 Apr 4.

    PubMed 24709487

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel and vandetanib in people with Fallopian Tube Cancer and Ovarian Cancer, run by SWOG Cancer Research Network at 137 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00872989, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.

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