Esophageal CancerPhase 2NCT00004897
Combination Chemotherapy and Interferon Alfa Followed by Surgery and/or Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer
A Phase 2 study testing recombinant interferon alfa, cisplatin and fluorouracil in people with Esophageal Cancer, run by Northwestern University at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- recombinant interferon alfa, cisplatin and fluorouracil
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Nov 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage I-III squamous cell carcinoma or adenocarcinoma of the esophagus and gastro-esophageal junction Unidimensionally measurable disease
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 270 days Hematopoietic: WBC greater than 3,000/mm3 Granulocyte count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin, alkaline phosphatase, and SGOT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine less than 2.0 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular: No serious cardiovascular disease that would preclude study Other: No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer No serious chronic medical illness that would preclude study No acute or chronic unresolved infection Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
About this study
Official title: PFL-Alpha Chemotherapy Followed by Surgery or FHX for Early Stage Esophageal Cancer - A Pilot Project
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with interferon alfa, surgery, and/or radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and interferon alfa followed by surgery and/or radiation therapy in treating patients who have stage I, stage II, or stage III esophageal cancer.
Read the detailed description
OBJECTIVES: I. Determine response rates, duration of response, and performance status in patients with stage I-III esophageal cancer after treatment with cisplatin, fluorouracil, interferon alfa, and leucovorin calcium. II. Determine toxicities of this regimen in these patients. III. Determine relapse and survival rates in this patient population treated with this regimen. IV. Determine response rates, duration of response, performance status, and relapse and survival rates for inoperable candidates in this patient population treated with this regimen followed by radiotherapy. V. Determine the toxicities of this regimen followed by radiotherapy in these patients. VI. Evaluate recurrence following this treatment regimen in this patient population. VII. Compare roentgenographic and ultrasound responses to histopathologic responses with this regimen in this patient population. VIII. Evaluate the effects of this regimen and its relation to the ability to achieve negative surgical margins and evaluate the extent of multifocality, nodal disease, tumor size, and tumor grade. IX. Determine the incidence of perioperative complications following this regimen, including surgical as well as operative time, blood loss, perioperative transfusions, and length of hospital stay.
OUTLINE: Patients receive leucovorin calcium IV continuously on days 1-5.5, interferon alfa subcutaneously daily on days 1-6, cisplatin IV over 6 hours on day 1, and fluorouracil IV continuously on days 1-5. Treatment continues every 21 days for 3 courses in the absence of unacceptable toxicity. Approximately 4 weeks after chemotherapy, esophagectomy is performed in patients without evidence of locally advanced unresectable esophageal cancer or distant metastases. Patients determined to have residual disease following esophagectomy will be considered for radiotherapy. Patients not undergoing esophagectomy receive chemoradiotherapy 21-28 days after completion of initial chemotherapy. Patients receive oral hydroxyurea every 12 hours on days 0-5 and fluorouracil IV continuously on days 1-5. Patients undergo radiotherapy to esophagus daily on days 1-5. Treatment continues every 14 days for 7 courses in the absence of unacceptable toxicity. Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 15-45 patients will be accrued for this study.
- Conditions
- Esophageal Cancer
- Being tested
- recombinant interferon alfa, cisplatin, fluorouracil, hydroxyurea, leucovorin calcium
- Keywords
- stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alfaBiological
cisplatinDrug
fluorouracilDrug
hydroxyureaDrug
conventional surgeryProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2004 (estimated)
- Study startOct 1999
- Primary completionJul 2007
- Study completionNov 2007
Why it stopped: Institutional Review Board requested termination - all patients deceased and no new accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Claudia Tellez, MD, Study chair, Hematology-Oncology Associates of Illinois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004897
- Sponsor's protocol ID
- NU 94I1
- Other IDs
- NU-94I1, NCI-G00-1679
- Status last verified
- Jun 2012
- First submitted
- 7 Mar 2000
- Last updated
- 12 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PFL-Alpha Chemotherapy Followed by Surgery or FHX for Early Stage Esophageal Cancer - A Pilot Project
- ClinicalTrials.gov ID
- NCT00004897
- Acronym / sponsor ID
- NU 94I1
- Conditions
- Esophageal Cancer
- Keywords
- stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Institutional Review Board requested termination - all patients deceased and no new accrual.
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1999
- Primary completion
- Jul 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 26 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with interferon alfa, surgery, and/or radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and interferon alfa followed by surgery and/or radiation therapy in treating patients who have stage I, stage II, or stage III esophageal cancer.
Detailed description
OBJECTIVES: I. Determine response rates, duration of response, and performance status in patients with stage I-III esophageal cancer after treatment with cisplatin, fluorouracil, interferon alfa, and leucovorin calcium. II. Determine toxicities of this regimen in these patients. III. Determine relapse and survival rates in this patient population treated with this regimen. IV. Determine response rates, duration of response, performance status, and relapse and survival rates for inoperable candidates in this patient population treated with this regimen followed by radiotherapy. V. Determine the toxicities of this regimen followed by radiotherapy in these patients. VI. Evaluate recurrence following this treatment regimen in this patient population. VII. Compare roentgenographic and ultrasound responses to histopathologic responses with this regimen in this patient population. VIII. Evaluate the effects of this regimen and its relation to the ability to achieve negative surgical margins and evaluate the extent of multifocality, nodal disease, tumor size, and tumor grade. IX. Determine the incidence of perioperative complications following this regimen, including surgical as well as operative time, blood loss, perioperative transfusions, and length of hospital stay.
OUTLINE: Patients receive leucovorin calcium IV continuously on days 1-5.5, interferon alfa subcutaneously daily on days 1-6, cisplatin IV over 6 hours on day 1, and fluorouracil IV continuously on days 1-5. Treatment continues every 21 days for 3 courses in the absence of unacceptable toxicity. Approximately 4 weeks after chemotherapy, esophagectomy is performed in patients without evidence of locally advanced unresectable esophageal cancer or distant metastases. Patients determined to have residual disease following esophagectomy will be considered for radiotherapy. Patients not undergoing esophagectomy receive chemoradiotherapy 21-28 days after completion of initial chemotherapy. Patients receive oral hydroxyurea every 12 hours on days 0-5 and fluorouracil IV continuously on days 1-5. Patients undergo radiotherapy to esophagus daily on days 1-5. Treatment continues every 14 days for 7 courses in the absence of unacceptable toxicity. Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 15-45 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| cisplatin | Drug | – |
| fluorouracil | Drug | – |
| hydroxyurea | Drug | – |
| leucovorin calcium | Drug | – |
| conventional surgery | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Institutional Review Board requested termination - all patients deceased and no new accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Tellez, MD study chair
Hematology-Oncology Associates of Illinois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant interferon alfa, cisplatin and fluorouracil in people with Esophageal Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Institutional Review Board requested termination - all patients deceased and no new accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2012; AzTrials last refreshed its copy on 7 Nov 2026.