Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Oxaliplatin

Antimetabolites

Weeks 1-6:

Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8

Weeks 7-12:

Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday

Evaluation for response and resection surgery

Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.

Induction Therapy - Capecitabine

Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle.

Induction Therapy - Oxaliplatin

Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.

Combination Therapy - Capecitabine

Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.

Combination Therapy - Oxaliplatin

1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.

Combination Therapy - Radiation

Four to eight weeks following the completion of therapy subjects will undergo evaluation for response and surgical resection.

Evaluation for response and surgery

Mary Mulcahy, MD

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with esophageal or gastroesophageal junction cancer.

OBJECTIVES:

Primary

* Determine the pathologic complete response in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising capecitabine, oxaliplatin, and radiotherapy.

Secondary

* Determine the clinical response rate in patients treated with this regimen.
* Determine the recurrence rate, time to progression, and patterns of failure in patients treated with this regimen.
* Characterize the toxicity profile of this regimen in these patients.

OUTLINE:

* Induction therapy: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
* Combination chemoradiotherapy: Patients then receive oxaliplatin IV over 2 hours once weekly for 6 weeks. Patients also receive concurrent oral capecitabine twice daily and undergo radiotherapy once daily 5 days a week for 5½ weeks in the absence of disease progression or unacceptable toxicity.
* Surgery: Patients undergo surgical resection at 4-8 weeks after completion of chemoradiotherapy.

After completion of study treatment, patients are followed every 3 months.

Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer

A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma

Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections.

Pathologic response will be defined as:

P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer

Clinical response Rate will be expressed as the proportion of patients demonstrating a complete and/or partial response based on all evaluable patients treated.Clinical response will be evaluated according to Response Evaluation Criteria In Solid Tumors 1.0 (RECIST) .

Complete Response (CR) is defined as the disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,taking as reference the baseline sum LD

Recurrence rate will be defined as disease recurrence, progressive disease or death. Patients will be followed for disease recurrence or death until the end of the study.

Time to Progression will be measured as time from the first day of therapy until death, disease progression or last contact.

Toxicity will be assessed at the beginning of every cycle during chemotherapy for a total of 4 cycles (1 cycle =21 days) and then 30 days post last dose of chemotherapy. All toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0)

In general adverse events (AEs) will be graded according to the following:

Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Only incidents of AEs determined to be related to chemotherapy are recorded here.

Northwestern University

For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.

Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:

Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.

Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.

Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:

Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.

Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.

Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.

4-6 weeks later subjects will undergo evaluation for response and surgical resection.

Induction and Combination Treatment

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Patients that completed induction of capecitabine and oxaliplatin, were then enrolled and completed treatment in capecitabine, oxaliplatin, and radiation.

Dr. Mary Mulcahy

Induction, Combination and Surgery

Patients analyzed were patients that reached and completed surgery.

Determine Pathologic Complete Response

1 patient was registered to the study but was not treated on study and was therefore not evaluable.

Clinical Response Rate

1 patient was registered but not treated on study and therefore was not evaluable.

Recurrence Rate

Data collected was not analyzed before the study was terminated. Count of participants indicates the number of patients with progressive disease or death at the time the study closed permanently.

Time to Progression

No data collected for this outcome measure. There is no data to report on.

Patterns of Failure

Thrombocytopenia

Anemia

lymphopenia

Leukopenia

Neutropenia

Thrombosis

Nausea

Diarrhea

Dysphagia

Vomiting

Constipatation

Abdominal pain

Stomatitis

Esophgitis

Toxicity data was collected and analysed for the first 40 patients.

Toxicity Profile

No data was collected for this outcome measure. There is no data to report on.

Correlate Proteomic and Pharmacologic Characteristics With Prognosis and Response to Therapy.

3 months

6 months

12 months

24 months

The only data collected for this outcome measure was progression free survival rate at 3 months, 6 months, and 12 months.

Determine Progressive Free Survival

1 patient was registered to the study, but was not treated on study and was therefore not evaluable. Data for overall surivival was collected at 3 months, 6 months, 12 months and 24 months. There was no further data analysis completed

Spots Global Cancer Trial Database for evaluation for response and surgery