Clinical trial · Interventional
Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer
A Mechanistic Radiographic and Biologic Phase 2 Single Agent Study of Sunitinib Malate in Relapsed/Refractory Esophageal and Gastroesophageal Cancers
NCT00702884CI-TRIAL-00026551completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Sunitinib 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. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory esophageal or gastroesophageal junction cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib
- description
- Sunitinib 37.5 mg daily for a 4 week cycle
- interventionNames
- Drug: sunitinib malate
Primary outcomes (1)
- measure
- Progression-free Survival Rate
- timeFrame
- up to 24 weeks
- description
- Complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks
Secondary outcomes (6)
- measure
- Overall Response Rate
- timeFrame
- up to 4 years
- description
- The Overall Response Rate (ORR) was assessed using Partial Response + Complete Response for patients. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed esophageal or gastroesophageal junction carcinoma that is not amenable to curative surgery or other curative therapy * Advanced, relapsed or refractory disease * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan * No known brain metastases PATIENT CHARACTERISTICS: * ECOG (Eastern Cooperative Oncology Group) performance status 0-1 * Life expectancy \> 12 weeks * WBC ≥ 3,000/μL * Absolute neutrophil count ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Serum calcium ≤ 12.0 mg/dL * Total bilirubin normal * AST (aspartate aminotransferase) and ALT (Alanine Aminotransferase) ≤ 2.5 times upper limit of normal * Creatinine normal OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception prior to, during, and for 28 days after completion of study treatment * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate * No ongoing cardiac dysrhythmias ≥ grade 2, atrial fibrillation of any grade, or prolongation of the QTc (corrected QT interval) interval to \> 450 msec (for males) or \> 470 msec (for females) * No hypertension that cannot be controlled by medications (i.e., systolic/diastolic blood pressure \> 150/100 mm Hg despite optimal medical therapy) * No myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months * No cerebrovascular accident or transient ischemic attack within the past 12 months * No pulmonary embolism within the past 12 months * No condition that would impair the ability to swallow and retain sunitinib malate tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days * No serious or nonhealing wound, ulcer, or bone fracture * No pre-existing thyroid abnormality that cannot be maintained in the normal range with medication * No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situation that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * At least 4 weeks since prior radiotherapy or major surgery * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C, carmustine, or alkylating agents) * No more than 6 prior courses of an alkylating agent * No more than 450 mg/m² of prior doxorubicin hydrochloride or 900 mg/m² of prior epirubicin hydrochloride * No more than 2 lines of prior therapy in the metastatic setting * No prior anti-VEGF monoclonal antibodies, such as bevacizumab or aflibercept * No prior tyrosine kinase inhibitors with similar targets (e.g., sorafenib tosylate or axitinib) * No other concurrent investigational agents * No concurrent therapeutic doses of coumarin-derivative anticoagulants, such as warfarin * Warfarin at doses of ≤ 2 mg daily are allowed for prophylaxis of thrombosis * Low molecular weight heparin allowed provided PT/INR (Prothrombin time and international normalized ratio) is ≤ 1.5 * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent agents with proarrhythmic potential (e.g., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide)
References
Publications (1)
- RESULTWu C, Mikhail S, Wei L, Timmers C, Tahiri S, Neal A, Walker J, El-Dika S, Blazer M, Rock J, Clark DJ, Yang X, Chen JL, Liu J, Knopp MV, Bekaii-Saab T. A phase II and pharmacodynamic study of sunitinib in relapsed/refractory oesophageal and gastro-oesophageal cancers. Br J Cancer. 2015 Jul 14;113(2):220-5. doi: 10.1038/bjc.2015.197. Epub 2015 Jul 7. PMID 26151457