SWOG clinical trial number
S0904
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
Closed
Phase
Accrual
99%
Published
Abbreviated Title
Randomized Ph II Ovarian vandetanib + docetaxel
Activated
03/15/2010
Closed
08/01/2011
Participants
Research committees
Gynecologic Cancer
Treatment
Docetaxel
ZD6474
Eligibility Criteria Expand/Collapse
Recurrent, refractory, or progressive/persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of original primary tumor. Must seek additional pt consent for submission of specimens. Must meet criteria regarding prior tx as described in Sections 5.4 and 5.5. Effects of prior tx must have resolved to </= Grade 1. Hormonal tx directed at malignant tumor must be discontinued at least 7 days prior to reg. Any other tx directed at malignant tumor must be discontinued at least 28 days prior to reg. Must not have received chemo for any abdominal or pelvic tumor within the last 5 years other than for the tx of ovarian, fallopian tube, or primary peritoneal cancer. No investigational agents within 28 days prior to reg. Must not have received RT to more than 25% of marrow-bearing areas. No RT within 28 days prior to reg. Must not have received prior RT to any portion of the abdominal cavity or pelvis within the last 5 years other than for the tx of ovarian, fallopian tube, or primary peritoneal cancer. No major surgery, open biopsy, or significant traumatic injury within 28 days prior to reg. No minor surgery, fine needle aspirates, or core biopsies within 7 days prior to reg. Zubrod 0-2. No neuropathy >/= Grade 2. No medications that are potent inducers of CYP3A4 within 2 weeks prior to reg. No active infection requiring systemic or intravenous antibiotics. Must not anticipate the need for major surgical procedures during study. Must not have uncontrolled hypertension within 28 days prior to registration. Within 3 months prior to reg: No myocardial infarction, superior vena cava syndrome, NYHA classification of heart disease >/= 2. No history of arrhythmia that is symptomatic or requires treatment. No history of asymptomatic sustained ventricular tachycardia. No QTc prolongation with other medications that required discontinuation of that medication. No congenital long QT syndrome or first degree relative with unexplained sudden death under 40 years of age. No presence of left bundle branch block. Must not be taking any medication that is generally accepted to have a risk of QTc prolongation or induce Torsades de Pointes. Within 7 days prior to reg: serum pregnancy test for women of child-bearing potential. Within 28 days prior to reg: assessments for measurable dz; ANC >/= 1,500/mcl; platelets >/= 100,000/mcl; serum creatinine </= IULN or calculated creatinine clearance >/= 30 ml/min; UPCR < 1; bilirubin </= 1.5 x IULN; AST or ALT or alkaline phosphatase </= 2.5 x IULN (</= 5 x IULN if liver mets present); CA-125. Within 42 days prior to reg: assessments for non-measurable dz; ECG.
Publication Information Expand/Collapse
2014
2012
Randomized phase II study of docetaxel plus vandetanib (V+D) versus docetaxel followed by vandetanib (D --> V) in patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (OC): SWOG S0904