FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer
Completed · Phase 2 · Has a placebo group
Conditions studied: Esophageal Cancer, Gastric Cancer
In brief
Anti-angiogenic therapy is a proven therapeutic target in refractory gastric and gastroesophageal junction adenocarcinoma. This trial assessed whether the addition of a high affinity angiogenesis inhibitor, ziv-aflibercept, could improve the efficacy of first-line mFOLFOX6 (oxaliplatin, leucovorin, and bolus plus infusional 5- fluorouracil) chemotherapy in metastatic esophagogastric adenocarcinoma. In this study (ZAMEGA), patients with treatment-naïve esophagogastric adenocarcinoma were randomly assigned 2:1 in a multicenter, placebo-controlled double-blind trial to receive first-line mFOLFOX6 with or without ziv-aflibercept 4mg/kg every 2 weeks. Randomization was stratified by ECOG performance status (0-1 vs. 2) and primary site of disease (esophagus or GE junction vs stomach).
Key facts
- Study ID
- NCT01747551
- Run by
- Dana-Farber Cancer Institute
- People needed
- 64
- Starts
- 2013-01-01
- Expected to finish
- 2017-07-26
- Last updated by the study team
- 2020-02-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed adenocarcinoma of esophagus, GE junction or gastric origin
- Disease is not amenable to curative resection and is unresectable, locally advanced or metastatic
- Have not received any prior chemotherapy, investigative or biologic agents for esophagogastric cancer except in the neoadjuvant or adjuvant setting
- Any major surgery must be completed at least 4 weeks prior to study entry, minor procedures must be completed at least 2 weeks prior to study entry
- Vascular access device insertion should be performed at least 1 week prior to study entry. A central line is recommended for all participants
- Willing to use adequate contraception prior to study entry, for the duration of study participation and for 3 months after the last dose of Ziv-aflibercept/placebo
You may not qualify if…
- History of hypertension unless adequately controlled
- Evidence of active bleeding from primary tumor at time of study entry
- Pregnant or breastfeeding
- Squamous cell carcinoma histology
- Prior treatment for advanced or metastatic disease
- Palliative radiation to < 25% of bone marrow must have been completed 2 weeks prior to study entry, palliative RT to > 25% must have been completed 4 weeks prior to study entry
- Known allergy to study agents
- Known dihydropyrimidine dehydrogenase deficiency or thymidylate kinase gene polymorphism predisposing participant to 5-FU toxicity
- History of symptomatic congestive heart failure
- Clinically significant peripheral arterial disease
- Grade 2 or higher sensory or motor neuropathy
- Serious unhealed wound, ulcers or bone fractures
- History of HIV positivity or hepatitis B or C
- History of abdominal fistula, wound dehiscence, GI perforation, intra abdominal abscess, uncontrolled GI bleeding or diverticulitis that required hospitalization within 6 months of study entry
- History of arterial thrombotic events
- History of CNS hemorrhage in past 6 months
- Use of warfarin
- History of prior or synchronous malignancy except if treated with curative intent more than 3 years prior to enrollment, or adequately treated non-melanoma skin cancers, cervical carcinoma in situ or prostatic intraepithelial neoplasia without evidence of prostate cancer
- Uncontrolled non-malignant illness
- Uncontrolled psychiatric illness
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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