Phase 2
N=12
Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction
Adenocarcinoma of the Gastroesophageal Junction · Esophageal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00891878 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Jul 2018
Primary outcome: Primary: Comparison of Progression-free Survival — 6.1; 2.4 Months — p=0.43
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- capecitabine (Drug); sunitinib malate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Progression-free Survival |
6.1; 2.4 | 0.43 |
| SECONDARY Response Rate (Complete Response or Partial Response) |
0; 33 | 0.45 |
| SECONDARY Overall Survival |
6.2; 5.9 | — |
| SECONDARY Time to Disease Progression |
7.56; 2.46 | — |
| SECONDARY Time to Treatment Failure |
1.63; 2.53 | — |
| SECONDARY Duration of Response |
4.75 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate 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 capecitabine is more effective when given alone or together with sunitinib malate in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.
PURPOSE: This randomized phase II trial is studying how well capecitabine works compared with capecitabine given together with sunitinib malate as first-line therapy in treating patients with metastatic cancer of the esophagus or gastroesophageal junction.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
- Metastatic disease
- Unresectable disease with no curative options
- Measurable disease with ≥ 1 lesion whose longest diameter can be accurately measured as ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT
- Not a candidate for a conventional multi-drug chemotherapy regimen with fairly standard dosing (i.e., patient is able to tolerate at least 80% of standard dosing)
- Patients who have been offered and declined conventional multi-drug chemotherapy are eligible
- No known CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 and age ≥ 65 years OR PS 2 and age ≥ 18 years but 30% of the marrow cavity at any time
- More then 4 weeks since prior major surgery
- At least 12 days since prior and no concurrent CYP3A4 inducers, including rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John's wort, efavirenz, and tipranavir
- At least 7 days since prior and no concurrent CYP3A4 inhibitors, including azole antifungals (ketoconazole, itraconazole), clarithromycin, erythromycin, diltiazem, verapamil, HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir), and delavirdine
- No other concurrent specific treatment (other than hormonal therapy) in patients with a history of prior malignancy
Data sourced from ClinicalTrials.gov (NCT00891878). 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.