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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00872989
First received: March 31, 2009
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: docetaxel
Drug: vandetanib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response (complete and partial) [ Time Frame: every 6 weeks until progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: every 3 months for two years and then every 6 months for 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2010
Estimated Study Completion Date: October 2016
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: docetaxel
Given IV
Drug: vandetanib
Given orally
Experimental: 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.
Drug: docetaxel
Given IV
Drug: vandetanib
Given orally

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872989

  Show 137 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Robert L. Coleman, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00872989     History of Changes
Other Study ID Numbers: CDR0000638595, S0904, U10CA032102
Study First Received: March 31, 2009
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
recurrent ovarian epithelial cancer
recurrent fallopian tube cancer
recurrent primary peritoneal cavity cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014