Combination Chemotherapy and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer

Esophageal Cancer Clinical Trial

Official title:

A Phase I Study of Oral Capecitabine in Combination With Weekly IV Carboplatin/Paclitaxel and Radiation Therapy for Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281788
• Other study ID #: 4950
• Secondary ID: DUMC-4950-05-8R2
• Status: Completed
• Phase: Phase 1
• First received: January 24, 2006
• Last updated: March 20, 2013
• Start date: September 2003
• Est. completion date: July 2007

Study information

• Verified date: April 2008
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, carboplatin, and paclitaxel, 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 together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal cancer or gastroesophageal junction cancer.

Description:

OBJECTIVES:

Primary

• Determine the maximum tolerated dose and recommended phase II dose of capecitabine when administered with carboplatin, paclitaxel, and radiotherapy in patients with carcinoma of the esophagus or gastroesophageal junction.

Secondary

• Determine the radiographic and pathologic response rate in patients treated with this regimen.

• Correlate, preliminarily, tumor biomarker response with clinical response in patients treated with this regimen.

OUTLINE: This is an open-label, dose-escalation study of capecitabine.

Patients undergo radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 and carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on day 2. Treatment repeats weekly for 5 weeks in the absence of disease progression or unacceptable toxicity. Beginning at week 9 (4 weeks after completing chemoradiotherapy), some patients may undergo surgery to remove the tumor. Patients with unresectable or gross residual disease after completing radiotherapy may continue to receive capecitabine, carboplatin, and paclitaxel for as long as the chemotherapy is beneficial.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed carcinoma of the thoracic esophagus or gastroesophageal junction for which bimodality treatment with chemotherapy and radiotherapy is indicated

• No tumors that extend above the level of the thoracic inlet or beyond 4 cm below the gastroesophageal junction

• No esophageal perforation based on radiographic or bronchoscopic evidence

• No known brain metastases, lymphangitic lung metastases, or carcinomatous meningitis

PATIENT CHARACTERISTICS:

• Karnofsky performance status = 70%

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

• AST or ALT = 2.5 times upper limit of normal (ULN)

• Bilirubin = 1.5 mg/dL

• Creatinine = 1.5 times ULN

• Calcium = 1.3 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection or other serious underlying medical condition that would preclude study treatment

• No dementia or significantly altered mental status that would preclude understanding or giving informed consent

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy

• No other concurrent investigational therapy

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• capecitabine

• carboplatin

• paclitaxel

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,