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Clinical Trials
NCT00872989

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

Last Updated: 2016-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer

Keywords

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recurrent ovarian epithelial cancer recurrent fallopian tube cancer recurrent primary peritoneal cavity cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

docetaxel

Intervention Type DRUG

Given IV

vandetanib

Intervention Type DRUG

Given orally

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.

Group Type EXPERIMENTAL

docetaxel

Intervention Type DRUG

Given IV

vandetanib

Intervention Type DRUG

Given orally

Interventions

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docetaxel

Given IV

Intervention Type DRUG

vandetanib

Given orally

Intervention Type DRUG

Eligibility Criteria

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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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert L. Coleman, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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Providence Cancer Center at Providence Hospital

Mobile, Alabama, United States

Site Status

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, United States

Site Status

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

NEA Medical Center - Stadium Boulevard

Jonesboro, Arkansas, United States

Site Status

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States

Site Status

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

Burbank, California, United States

Site Status

Peninsula Medical Center

Burlingame, California, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, United States

Site Status

El Camino Hospital Cancer Center

Mountain View, California, United States

Site Status

Highland General Hospital

Oakland, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

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

Orange, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

California Pacific Medical Center - California Campus

San Francisco, California, United States

Site Status

Doctors Medical Center - San Pablo Campus

San Pablo, California, United States

Site Status

Sutter Health - Western Division Cancer Research Group

San Rafael, California, United States

Site Status

Tahoe Forest Cancer Center

Truckee, California, United States

Site Status

Sutter Solano Medical Center

Vallejo, California, United States

Site Status

San Luis Valley Regional Medical Center

Alamosa, Colorado, United States

Site Status

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Site Status

Shaw Regional Cancer Center

Edwards, Colorado, United States

Site Status

Valley View Hospital Cancer Center

Glenwood Springs, Colorado, United States

Site Status

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

Grand Junction, Colorado, United States

Site Status