Clinical Trials Logo

Clinical Trial Summary

The purpose of this research study is to determine if the combination of docetaxel, cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric cancer and how the cancer responds to this combination. Bevacizumab is a new drug that is believed to stop the formation of new blood vessels that carry nutrients to tumors. Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin and irinotecan are traditional chemotherapy agents that have been tested together in another clinical trial for esophageal and gastric cancer. Of the 40 patients on this trial, 60% of the patients showed a response of some kind and the regimen was well tolerated. It is hoped that adding bevacizumab to this regimen will make the treatment more effective.


Clinical Trial Description

Participants' chemotherapy will be given once a week for two weeks in a row, with a rest period on the third week. This three week period of time is called a cycle.

Week 1 (Cycle 1): The nurse in the infusion clinic will start an intravenous line to give premedications, fluid and the chemotherapy. Bevacizumab is only given on day 1 of each cycle and is infused over 90 minutes. Docetaxel, cisplatin and irinotecan will each be given over 30 minutes.

Week 2 (Cycle 1): The following tests and procedures will be performed prior to the administration of chemotherapy; blood tests, height, weight, vital signs, review of medications and any side effects. Once the tests and procedures are complete, docetaxel, cisplatin and irinotecan will each be administered over 30 minutes.

If the participants' cancer is still present in the esophagus or stomach, the doctor will offer the option of reevaluating the tumor with endoscopy. The doctor will look for signs that the tumor is dying and any evidence of bleeding. A biopsy will be done during this procedure.

Week 1 (Cycle 2 and all future cycles): On day one of each cycle the participant will undergo the following: Medical history and physical exam including vital signs; blood tests; bevacizumab, docetaxel, cisplatin and irinotecan infusions.

Week 2 (Cycle 2 and all future cycles): The following tests and procedures will be performed: blood tests; vital signs; side effect evaluation; docetaxel, cisplatin and irinotecan infusions.

After every 2 cycles of chemotherapy, a urinalysis to test for protein in the urine, and CT scans to measure the tumor will be performed.

Participants will be in this research study for at least 2 cycles. After the CT scan, if the study doctor thinks this regimen of chemotherapy is helping and the tumors are stable or shrinking, the participant can continue on the study. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00394433
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 2006
Completion date June 2016

See also
  Status Clinical Trial Phase
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
Not yet recruiting NCT05542680 - Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer N/A
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Completed NCT00003864 - Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus Phase 2
Recruiting NCT05491616 - Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Completed NCT00199849 - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Phase 1
Completed NCT03756597 - PAN-study: Pan-Cancer Early Detection Study (PAN)
Completed NCT00400114 - Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT04615806 - The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy N/A
Active, not recruiting NCT04566367 - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer N/A
Active, not recruiting NCT03962179 - Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent) N/A
Terminated NCT01446874 - Prevention of Post-operative Pneumonia (POPP) Phase 2/Phase 3
Completed NCT03468634 - Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy N/A
Active, not recruiting NCT02869217 - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors Phase 1
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT01404156 - Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma Phase 2/Phase 3