Expired Study
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Cleveland, Ohio 44106


Purpose:

RATIONALE: Drugs used in chemotherapy, such as epirubicin, oxaliplatin, fluorouracil, and cisplatin, 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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving combination chemotherapy, surgery, and radiation therapy works in treating patients with locoregionally advanced cancer of the esophagus, gastroesophageal junction, or stomach.


Study summary:

OBJECTIVES: Primary - To assess the feasibility and tolerability of induction chemotherapy comprising epirubicin hydrochloride, oxaliplatin, and fluorouracil (EOF), followed by surgical resection and postoperative concurrent chemoradiotherapy comprising fluorouracil and cisplatin in patients with locoregionally advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia. Secondary - To determine the rate of complete and partial response to three courses of EOF induction chemotherapy. - To compare the recurrence-free and overall survival of patients treated with this regimen vs historical controls at this institution. - To compare patterns of failure in patients treated with this regimen vs historical controls at this institution. OUTLINE: - Induction chemotherapy: Patients receive epirubicin hydrochloride IV over 3-15 minutes and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-21. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. - Surgery: Four weeks after completion of induction chemotherapy, patients with locoregionally confined disease (T0-4, N0-1, M0-1a) undergo transthoracic esophagogastrectomy or total gastrectomy with Roux-en-Y esophagojejunostomy, depending on the location and extent of the tumor at the time of surgery. - Postoperative chemoradiotherapy: Beginning 6-10 weeks after surgery, patients undergo radiotherapy 5 days a week for approximately 6 weeks. Patients also receive fluorouracil IV continuously and cisplatin IV continuously over 96 hours in weeks 1 and 4 of radiotherapy. After completion of study treatment, patients are followed every 8-12 weeks for 3 years.


Criteria:

Inclusion Criteria: - Patients must have a histologic diagnosis of adenocarcinoma of the esophagus, gastroesophageal junction or gastric cardia, based on biopsy material or adequate cytologic exam. - Patients must be clinically staged according to the AJCC 2002 staging system and must have either T3-4, or N1 or M1a disease. Staging should include at least an upper endoscopy with endoscopic ultrasound and an FDG-PET/CT scan. - Patients must have an ECOG performance status of 0-1. - Patients must have adequate bone marrow function as evidenced by: Absolute neutrophil count > 1,500/uL Platelet count > 100,000/uL - Patients must have adequate renal function as evidenced by serum creatinine < 1.6 mg/dL - Patients must have adequate hepatic function as evidenced by:Serum total bilirubin < 1.5 mg/dL Alkaline phosphatase < 3X the institutional ULN AST/ALT < 3X the institutional ULN - Patients must have adequate pulmonary function as evidenced by an FEV1 > 50% predicted. - Patients or their legal representatives must be able to read, understand, provide and sign informed consent to participate in the trial. - Patients of childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method) - Age > 18 years Exclusion Criteria: - Patients with any other diagnosis except for adenocarcinoma (squamous cell carcinoma, small cell carcinoma, mixed adenosquamous, lymphoma, sarcoma etc,) will be ineligible. - Patients with any evidence of distant hematogenous or distant nodal disease (M1b) will be ineligible. - No prior chemotherapy, radiation therapy or surgery for this malignancy will be allowed. Prior endoscopic debulking, laser therapy or dilatation will not exclude a patient. - Patients with another active malignancy will not be eligible except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations at least 3 months apart, with the most recent evaluation within 4 weeks of entry - Patients with an active infection will not be eligible. - Patients with known hypersensitivity to any of the components of oxaliplatin, epirubicin, fluorouracil or cisplatin will not be eligible. - Patients who are receiving any other concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication) will not be eligible. - Patients with a baseline peripheral neuropathy greater than or equal Grade 2 will not be eligible. - Patients who are pregnant or lactating will not be eligible. - Patients with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results, will not be eligible. - Patients with any history of an allogeneic transplant will not be eligible. - Patients with known infection with HIV, Hepatitis B or C (active, previously treated or both) will not be eligible.


Study is Available At:


Original ID:

CASE2Y07


NCT ID:

NCT00601705


Secondary ID:

P30CA043703


Study Acronym:


Brief Title:

Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junction, or Stomach


Official Title:

A Phase II Trial of Induction Chemotherapy With Epirubicin, Oxaliplatin and Fluorouracil (EOF) Followed by Esophagogastrectomy and Post-operative Concurrent Chemoradiotherapy With Fluorouracil and Cisplatin, in Patients With Loco-regionally Advanced Adeno


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Case Comprehensive Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

61


Enrollment Type:

Actual


Overall Contact Information

Official Name:David J. Adelstein, MD
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Dates

Start Date:January 5, 2008
Completion Date:January 23, 2015
Completion Type:Actual
Primary Completion Date:March 26, 2012
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 18, 2019
First Received Date:January 23, 2008
First Results Date:February 21, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Feasibility of Induction Chemoradiotherapy as Measured by Resectability Rate
Time Frame:at 12 weeks from on study
Safety Issues:False
Description:Feasibility of induction chemoradiotherapy as measured by resectability in greater than 75% of participants. The number of participants that were resectable.
Outcome Type:Secondary Outcome
Measure:Clinical Response Rate
Time Frame:at 12 weeks from on study
Safety Issues:False
Description:Percent of participants with a clinical response: Complete clinical response is defined as the complete disappearance of all clinical evidence of tumor. Partial clinical response is defined as any improvement in the clinically determined T or N stage (w
Outcome Type:Secondary Outcome
Measure:Pathological Response Rate
Time Frame:after completion of study at 35 weeks
Safety Issues:False
Description:Percent of participants with a clinical response: Complete pathologic response is defined as the complete disappearance of all viable tumor in the surgical specimen. Partial pathologic response is defined as any improvement in the pathologically determi
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:at 3 years from on study
Safety Issues:False
Description:Percent of participants with a 3-year survival. A survival rate greater than 50% would suggest efficacy and justify further study.
Outcome Type:Secondary Outcome
Measure:Locoregional Control and Distant Metastatic Control
Time Frame:at 3 years from on study
Safety Issues:False
Description:A distant metastatic control rate of greater than 55 % would suggest efficacy for this treatment protocol. A locoregional control rate of less than 75% would suggest inefficacy. Locoregional control (LRC) defined by recurrence at the primary site or in re
Outcome Type:Secondary Outcome
Measure:Postoperative Adjuvant Chemoradiotherapy Feasibility
Time Frame:Between 6 to 10 weeks postoperatively
Safety Issues:False
Description:Ability to complete postoperative chemoradiotherapy. A threshold level of 65% was set and if less than this percentage completed the phase, it would be deemed unacceptable. The anticipation was that 53-patients would be evaluable for this end point.

Study Interventions

Intervention Type:Drug
Name:cisplatin
Description:20 mg/m2/day IV continuous infusion over 24 hours for 96 total hours.
Arm Name:Epirubicin, Oxaliplatin and Fluorouracil
Intervention Type:Drug
Name:epirubicin hydrochloride
Description:50 mg/m2 IV bolus
Arm Name:Epirubicin, Oxaliplatin and Fluorouracil
Intervention Type:Drug
Name:fluorouracil
Description:200 mg/m2/day will be given as a continuous intravenous infusion for all 9 weeks, beginning on day 1.
Arm Name:Epirubicin, Oxaliplatin and Fluorouracil
Intervention Type:Drug
Name:oxaliplatin
Description:130 mg/m2 IV infusion over 2 hours
Arm Name:Epirubicin, Oxaliplatin and Fluorouracil
Intervention Type:Procedure
Name:adjuvant therapy
Description:Between 6-10 weeks after surgery patients will begin postoperative chemoradiotherapy. Daily radiation therapy fractions of 180-200 cGy will be given to the esophago-gastric bed and draining lymphatic regions to a total dose of 50-55 Gy (60 Gy in the event of an R1 or R2 resection). Concurrent with this radiation, two cycles of chemotherapy will be given, during the first and fourth weeks of the radiation
Arm Name:Epirubicin, Oxaliplatin and Fluorouracil
Intervention Type:Procedure
Name:neoadjuvant therapy
Description:Three weeks after discontinuing the fluorouracil (12 weeks after study entry) patients will be fully restaged to assess for a clinical response, and to ensure that there is no contraindication to surgical resection, which will be scheduled for approximately one week later (13 weeks after study entry). Surgery will consist of a transthoracic esophagogastrectomy or a total gastrectomy with Roux-en-Y esophagojejunostomy depending on the location and extent of the tumor at surgery. An appropriate l
Arm Name:Epirubicin, Oxaliplatin and Fluorouracil

Study Arms

Study Arm Type:Experimental
Arm Name:Epirubicin, Oxaliplatin and Fluorouracil

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Case Comprehensive Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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