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

NCT ID: NCT00281788

Last Updated: 2013-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2007-07-31

Brief 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.

Detailed 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.

Conditions

Esophageal Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

capecitabine

Intervention Type: DRUG

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Principal Investigators

Herbert I. Hurwitz, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Cancer Institute

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DUMC-4950-05-8R2

Identifier Type: -

Identifier Source: secondary_id

CDR0000449942

Identifier Type: OTHER

Identifier Source: secondary_id

4950

Identifier Type: -

Identifier Source: org_study_id