Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT00006472

Collaborator

(none)

Enrollment

Locations

Arm

32.3

Duration (Months)

0.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy drugs and radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy given before surgery in treating patients who have stage I, stage II, or stage III esophageal cancer.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: carboplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES: I. Determine the total response rate in patients with stage I, II, or III esophageal cancer treated with paclitaxel, carboplatin, and fluorouracil with concurrent radiotherapy followed by surgical resection. II. Determine the overall survival of these patients treated with this regimen. II. Determine the toxicity of this regimen in this patient population.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1 and 22, and fluorouracil IV continuously on days 1-42. Patients undergo radiotherapy concurrently with chemotherapy daily 5 days a week for 5 weeks. Patients then undergo surgical resection within 3-5 weeks following completion of therapy. Patients are followed every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Esophageal Cancer: A Phase II Study of Paclitaxel, Carboplatin and 5-Fluorouracil With Simultaneous Radiotherapy Followed by Surgical Resection

Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Nov 15, 2001

Actual Study Completion Date :

Sep 10, 2002

Arms and Interventions

Arm	Intervention/Treatment
Other: Single arm study Taxol® (Paclitaxel), Carboplatin and 5-Fluorouracil with Simultaneous Radiotherapy Followed by Surgical Resection	Drug: carboplatin Carboplatin AUC 6 days 1 and 22 Other Names: paraplatin Drug: fluorouracil 5FU 225mg/m2 continuous infusion on days 1-42 during radiation Other Names: 5FU Drug: paclitaxel taxol Other Names: 200mg/m2 days 1 and 22 Procedure: conventional surgery Radiation: radiation therapy The initial fields should be treated AP:PA when possible to a dose of 4500 cGy in 180 cGy fractions

Arm

Intervention/Treatment

Other: Single arm study

Taxol® (Paclitaxel), Carboplatin and 5-Fluorouracil with Simultaneous Radiotherapy Followed by Surgical Resection

Drug: carboplatin

Carboplatin AUC 6 days 1 and 22

Other Names:

paraplatin

Drug: fluorouracil

5FU 225mg/m2 continuous infusion on days 1-42 during radiation

Other Names:

5FU

Drug: paclitaxel

taxol

Other Names:

200mg/m2 days 1 and 22

Procedure: conventional surgery

Radiation: radiation therapy

The initial fields should be treated AP:PA when possible to a dose of 4500 cGy in 180 cGy fractions

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the upper, middle, or lower third esophagus Stage I, II, or III disease Measurable disease No distant metastases Negative liver biopsy Negative bone scan unless due to benign disease No tracheobronchial involvement No vocal cord paralysis No phrenic nerve involvement No celiac axis lymph node involvement unless due to primary cancer at gastroesophageal junction No evidence of disseminated cancer

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:

Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No uncontrolled or severe cardiovascular disease No congestive heart failure No myocardial infarction within the past 6 months No severe or uncontrolled hypertension (systolic greater than 150 mmHg and diastolic greater than 100 mmHg) Pulmonary: FEV1/FVC at least 75% predicted Arterial blood saturation at least 92% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No other serious medical illness that would limit survival to fewer than 2 years No active uncontrolled bacterial, viral, or fungal infection No active uncontrolled duodenal ulcer No psychiatric disorder that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior chest radiotherapy Surgery: No prior surgical resection of tumor Other: No prior therapy for esophageal cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington Cancer Institute	Washington	District of Columbia	United States	20010
2	Washington Hospital Center	Washington	District of Columbia	United States	20010
3	Union Memorial Hospital	Baltimore	Maryland	United States	21218
4	Harbor Hospital Center	Baltimore	Maryland	United States	21225
5	Franklin Square Hospital Center	Baltimore	Maryland	United States	21237
6	Good Samaritan Hospital of Maryland	Baltimore	Maryland	United States	21239