Ganitumab and Gemcitabine Hydrochloride Followed by Radiation Therapy, Ganitumab, Capecitabine, and Maintenance Therapy in Treating Patients With Locally Advanced Cancer of the Pancreas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Monoclonal antibodies, such as ganitumab, 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 cancer-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of ganitumab when given together with gemcitabine hydrochloride followed by radiation therapy, ganitumab, capecitabine, and maintenance therapy in treating patients with locally advanced cancer of the pancreas.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES:

Primary

* To evaluate the maximum dose of ganitumab, up to a target dose of 20 mg/kg, given concurrently with capecitabine and radiotherapy following induction ganitumab and gemcitabine hydrochloride in patients with locally advanced pancreatic cancer.

Secondary

* To evaluate the safety profile of induction therapy comprising ganitumab and gemcitabine hydrochloride, followed by ganitumab and concurrent chemoradiation, and subsequently by maintenance ganitumab and gemcitabine hydrochloride until disease progression in patients with locally advanced pancreatic cancer.
* To evaluate response and overall survival of patients treated at the maximum dose of ganitumab given concurrently with capecitabine and radiotherapy following induction ganitumab and subsequently followed by maintenance ganitumab and gemcitabine hydrochloride until disease progression.

OUTLINE: This is a multicenter, dose-escalation study of ganitumab followed by an expanded cohort study.

Induction therapy: Patients receive ganitumab IV over 1-2 hours on days 1 and 15 and gemcitabine hydrochloride IV over 30 minutes on days 1, 15, and 22. Treatment repeats every 28 days for 2 courses.

Concurrent therapy: Beginning 10-28 days later, patients undergo 3-dimensional conformal radiotherapy once daily, 5 days a week for 5.5 weeks beginning on day 1. Patients also receive concurrent ganitumab IV over 1-2 hours on days 1, 15, and 29 and capecitabine orally (PO) twice daily on days 1-5 weekly for 5.5 weeks.

Maintenance therapy: Beginning 21-42 days later, patients receive ganitumab IV over 1-2 hours on days 1 and 15 and gemcitabine hydrochloride IV over 30 minutes on days 1, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 4 months for 1 year, and then annually thereafter.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

* No distant metastases based upon the following minimum diagnostic workup:

* History and/or physical examination, including collection of weight and vital signs, within 28 days prior to study entry
* Abdominal and/or pelvic CT scan with IV contrast or MRI scan within 21 days prior to study entry
* Chest CT scan or whole-body PET/CT within 21 days prior to study entry
* No second malignancy or peritoneal seeding

PATIENT CHARACTERISTICS:

* Zubrod performance status 0-1
* Absolute neutrophil count (ANC) ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin (Hgb) ≥ 10.0 g/dL (the use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dL is acceptable)
* Glycosylated hemoglobin (HgbA1c) ≤ 8%
* Serum creatinine ≤ 1.5 mg/dL
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 times upper limit of normal (ULN)
* Total bilirubin \< 3.0 mg/dL
* Alkaline phosphatase \< 3 times ULN
* Fasting blood glucose \< 160 mg/dL

* Patients with a non-fasting blood glucose \> 160 mg/dL (8.9 mmol/L) must have a fasting blood glucose ≤ 160 mg/dL (8.9 mmol/L) in order to be eligible
* No grade 2 or worse hearing impairment
* Negative serum pregnancy test (if applicable)
* Women of childbearing potential and men who are sexually active must be willing/able to use medically acceptable forms of contraception during the course of the study, and for 3 months (6 months for men) after the last study drug administration
* Not pregnant or nursing
* Ability to swallow oral medications
* At least 3 years since prior malignancy except non-melanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
* No severe active co-morbidity, defined as any of the following:

* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
* Transmural myocardial infarction within 6 months prior to study entry
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization, or precluding study therapy within 30 days before registration
* Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function
* Any unresolved bowel or bile duct obstruction
* Major resection of the stomach or small bowel that could affect the absorption of capecitabine
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition

* HIV testing is not required for entry into this protocol
* Existing venous thromboembolism requiring anti-coagulation therapy
* No prior allergic reaction to capecitabine or gemcitabine hydrochloride

PRIOR CONCURRENT THERAPY:

* No prior systemic chemotherapy for pancreatic cancer

* Prior chemotherapy for malignancies other than pancreatic cancer is allowed provided chemotherapy was completed \> 3 years prior to study entry
* No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* More than 28 days since any prior major surgery

* Insertion of a vascular access device, insertion of a biliary stent, exploratory laparotomy, or laparoscopy are not considered major surgery
* No prior ganitumab
* Patients requiring concurrent oral anticoagulants (e.g., Coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring international normalized ratio (INR)
* No concurrent participation in another clinical treatment trial
* No concurrent intensity-modulated radiotherapy
* No other concurrent therapy including the following:

* Other investigational or approved chemotherapeutic agents
* Other monoclonal antibody
* Sorivudine or brivudine A
* Cimetidine
* G-CSF agents

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christopher H. Crane, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Review additional registry numbers or institutional identifiers associated with this trial.

CDR0000695567

Identifier Type: -

Identifier Source: secondary_id

RTOG 1102

Identifier Type: -

Identifier Source: org_study_id

Ganitumab and Gemcitabine Hydrochloride Followed by Radiation Therapy, Ganitumab, Capecitabine, and Maintenance Therapy in Treating Patients With Locally Advanced Cancer of the Pancreas

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Arm A

ganitumab

capecitabine

gemcitabine hydrochloride

3-dimensional conformal radiation therapy

Arm B

ganitumab

capecitabine

gemcitabine hydrochloride

3-dimensional conformal radiation therapy

Arm C

ganitumab

capecitabine

gemcitabine hydrochloride

3-dimensional conformal radiation therapy

Arm D

ganitumab

capecitabine

gemcitabine hydrochloride

3-dimensional conformal radiation therapy

Arm E

ganitumab

capecitabine

gemcitabine hydrochloride

3-dimensional conformal radiation therapy

Arm F

ganitumab

capecitabine

gemcitabine hydrochloride

3-dimensional conformal radiation therapy

Interventions

ganitumab

capecitabine

gemcitabine hydrochloride

3-dimensional conformal radiation therapy

Eligibility Criteria

Inclusion Criteria

Sponsors

National Cancer Institute (NCI)

NRG Oncology

Radiation Therapy Oncology Group

Responsible Party

Principal Investigators

Christopher H. Crane, MD

Locations

St. Joseph Hospital Regional Cancer Center - Orange

CCOP - Christiana Care Health Services

James Graham Brown Cancer Center at University of Louisville

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

James P. Wilmot Cancer Center at University of Rochester Medical Center

Summa Center for Cancer Care at Akron City Hospital

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Rhode Island Hospital Comprehensive Cancer Center

Northmain Radiation Oncology

M. D. Anderson Cancer Center at University of Texas

Countries

Other Identifiers

CDR0000695567

RTOG 1102