Back to results

Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

cetuximab

capecitabine

oxaliplatin

conventional surgery

radiation therapy

Gemcitabine

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically or radiologically confirmed pancreatic cancer, meeting both of the following criteria:
- Locally advanced, nonmetastatic disease
- Surgically unresectable disease
Measurable disease, defined as unidimensionally measurable by physical exam or imaging study
- The following are considered nonmeasurable disease:
  - Bone-only disease
  - Pleural or peritoneal effusions
  - CNS lesions
  - Irradiated lesions in the absence of progression after radiotherapy
No history or evidence of CNS disease
No metastatic disease to distant organs (e.g., liver, lung, brain, or bone)

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Granulocyte count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 2.0 mg/dL
Creatinine ≤ 2.0 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 90 days after completion of study therapy
No acute hepatitis
No known HIV positivity
No active or uncontrolled infection
No significant history of uncontrolled cardiac disease, including, but not limited to, any of the following:
- Uncontrolled hypertension
- Unstable angina
- Myocardial infarction within the past 6 months
- Uncontrolled congestive heart failure
- Cardiomyopathy with decreased ejection fraction
No prior severe infusion reaction to a monoclonal antibody
No active second malignancy other than nonmelanoma skin cancer
No history of deep vein thrombosis
No history of bleeding diathesis or coagulopathy
No other severe concurrent disease, mental incapacitation, or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

No prior therapy for pancreatic cancer
No prior therapy specifically targeting the epidermal growth factor-receptor pathway
No major surgical procedure or open biopsy within the past 28 days
No prior radiotherapy or chemotherapy
No prior or concurrent full-dose anticoagulants or thrombolytics

Sites / Locations

Hollings Cancer Center at Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine,Oxaliplatin and Cetuximab

Arm Description

Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks. After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.

Outcomes

Primary Outcome Measures

Progression-free Survival at 6 Months

Secondary Outcome Measures

Number of Participants With Grade 3-4 Adverse Events Reported

Overall Survival

Response Rate

defined as the total number of subjects whose best response is PR or CR.

Response Duration in Patients With at Least Partial Response to Treatment

Determine the Biomarker Response of CA 19-9 to Therapy

Full Information

NCT ID

NCT00408564

First Posted

December 6, 2006

Last Updated

July 19, 2018

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT00408564

Brief Title

Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Official Title

Phase II Study of Neoadjuvant Gemcitabine/Oxaliplatin and Cetuximab Followed by Surgery or Concurrent External Beam Radiation With Capecitabine for Patients With Locally Advanced Unresectable Nonmetastatic Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cetuximab together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed. Giving cetuximab and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with oxaliplatin and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works in treating patients with locally advanced, nonmetastatic pancreatic cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES: Primary Determine the progression-free survival rate in patients with unresectable, locally advanced, nonmetastatic adenocarcinoma of the pancreas treated with neoadjuvant therapy comprising cetuximab, gemcitabine hydrochloride, and oxaliplatin followed by either surgery or chemoradiotherapy comprising external-beam radiotherapy and capecitabine. Secondary Determine the toxicity and tolerability of this regimen in these patients. Determine overall survival and progression-free survival. Determine the response rate in these patients. Determine the response duration (defined as the time from first observation response to the time of progressive disease) in patients who achieve at least a partial response to treatment. Determine the biomarker response of CA19-9. OUTLINE: This is an open-label study. Neoadjuvant therapy: Patients receive cetuximab IV over 1-2 hours on days 1 and 8, gemcitabine hydrochloride IV over 100 minutes on day 1, and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are evaluated after completion of neoadjuvant therapy. Patients with metastatic disease are taken off study. Beginning within 4 weeks after completion of neoadjuvant therapy, patients with resectable disease proceed to surgical resection or chemoradiotherapy (by choice); patients with unresectable disease proceed to chemoradiotherapy. Surgery: Patients undergo surgical resection with the Whipple procedure. Chemoradiotherapy: Patients receive oral capecitabine twice daily 5 days a week (on days 1-5) and undergo external-beam radiotherapy once daily 5 days a week for 5½ weeks. After completion of study treatment, patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine,Oxaliplatin and Cetuximab

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

cetuximab

Intervention Type

Drug

Intervention Name(s)

capecitabine

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Primary Outcome Measure Information:

Title

Progression-free Survival at 6 Months

Time Frame

up to 46 weeks after the start of study treatment

Secondary Outcome Measure Information:

Title

Number of Participants With Grade 3-4 Adverse Events Reported

Time Frame

from start of study treatment until end of study visit, about 30 weeks

Title

Overall Survival

Time Frame

up to 46 weeks after the start of study treatment

Title

Response Rate

Description

defined as the total number of subjects whose best response is PR or CR.

Time Frame

up to 46 weeks after the start of study treatment

Title

Response Duration in Patients With at Least Partial Response to Treatment

Time Frame

up to 46 weeks after the start of study treatment

Title

Determine the Biomarker Response of CA 19-9 to Therapy

Time Frame

from start up treatment to one year after end of treatment, up to 81 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically or radiologically confirmed pancreatic cancer, meeting both of the following criteria: Locally advanced, nonmetastatic disease Surgically unresectable disease Measurable disease, defined as unidimensionally measurable by physical exam or imaging study The following are considered nonmeasurable disease: Bone-only disease Pleural or peritoneal effusions CNS lesions Irradiated lesions in the absence of progression after radiotherapy No history or evidence of CNS disease No metastatic disease to distant organs (e.g., liver, lung, brain, or bone) PATIENT CHARACTERISTICS: ECOG performance status 0-2 Granulocyte count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Bilirubin ≤ 2.0 mg/dL Creatinine ≤ 2.0 mg/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 90 days after completion of study therapy No acute hepatitis No known HIV positivity No active or uncontrolled infection No significant history of uncontrolled cardiac disease, including, but not limited to, any of the following: Uncontrolled hypertension Unstable angina Myocardial infarction within the past 6 months Uncontrolled congestive heart failure Cardiomyopathy with decreased ejection fraction No prior severe infusion reaction to a monoclonal antibody No active second malignancy other than nonmelanoma skin cancer No history of deep vein thrombosis No history of bleeding diathesis or coagulopathy No other severe concurrent disease, mental incapacitation, or psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: No prior therapy for pancreatic cancer No prior therapy specifically targeting the epidermal growth factor-receptor pathway No major surgical procedure or open biopsy within the past 28 days No prior radiotherapy or chemotherapy No prior or concurrent full-dose anticoagulants or thrombolytics

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew S. Kraft, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gustavo Leone

Organizational Affiliation

Medical University of South Carolina, Hollings Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Hollings Cancer Center at Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Learn more about this trial

We'll reach out to this number within 24 hrs