Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction
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.
Adenocarcinoma of the Gastroesophageal Junction
Drug: sunitinib malate
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of Sunitinib Plus Capecitabine Versus Capecitabine Alone (With the Potential for Crossover) for Elderly and/or Poor Performance Status Patients With Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction|
- Comparison of progression-free survival [ Designated as safety issue: No ]
- Response rate (complete response or partial response) [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
- Crossover treatment analysis [ Designated as safety issue: No ]
- Protein markers as predictors of tumor response [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion.
Experimental: Arm II
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Given orallyDrug: sunitinib malate
- Compare the progression-free survival of elderly (age ≥ 65 years) and/or poor performance status patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with capecitabine with verus without sunitinib malate.
- Report other indicators of efficacy with these regimens, including the confirmed response rate, overall survival, time to tumor progression, duration of response, and time to treatment failure.
- Compare the adverse event profiles of these regimens in these patients.
- Explore whether certain key proteins associated with anti-VEGF therapy are able to predict tumor response.
- Bank paraffin-embedded tissue blocks or slides, and blood products for future studies.
OUTLINE: This is a multicenter study. Patients are stratified according to gender (male vs female), ECOG performance status (0 vs 1 vs 2), and age (≥ 65 years vs < 65 years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion.
- Arm II: Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected at baseline for evaluation of protein markers as possible predictors of tumor response to this regimen. Samples are analyzed by IHC for expression levels of markers
After completion of study therapy, patients are followed periodically for 3 years.