Phase 2
Completed N=129
S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Fallopian tube cancer · Ovarian Cancer · Primary Peritoneal Cavity Cancer
Source: ClinicalTrials.gov NCT00872989 ↗
Enrolled (actual)
129
Serious AEs
24.7%
Results posted
Dec 2016
Primary outcomePrimary: Progression Free Survival (PFS) — 3.5; 3.0 months — p=0.49
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
3.5; 3.0 | 0.49 |
| SECONDARY Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease |
0; 0; 5; 6; 1; 0 | — |
| SECONDARY Overall Survival |
18; 14 | 0.83 |
| SECONDARY Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs |
0; 1; 0; 0; 1; 0 | — |
| SECONDARY Time to Treatment Failure |
1.4 | — |
| SECONDARY 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 |
0; 0; 0; 1; 8; 20 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00872989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.