TerminatedNCT00878657Updated May 5, 2014

Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer

A Phase 1 interventional study of gemcitabine hydrochloride and intensity-modulated radiation therapy in Pancreatic Cancer, sponsored by Rutgers, The State University of New Jersey. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-05.

Sponsored by Rutgers, The State University of New Jersey · Phase 1, Interventional, and Treatment

Why this study was terminated

Slow accrual

Phase: Phase 1
Study type: Interventional
Enrollment: 8
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

RATIONALE: Specialized 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. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy together with gemcitabine may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy and to see how well it works when given together with gemcitabine in treating patients with locally advanced pancreatic cancer.

Read the detailed description

The study was terminated early due to slow accrual and only the phase I portion of hte study was opened. The phase of the study has been revised to only a phase I study.

OBJECTIVES:

To determine the maximum tolerated dose (MTD) of intensity-modulated radiotherapy delivered to the gross tumor volume when administered with gemcitabine hydrochloride in patients with locally advanced pancreatic carcinoma. (Phase I)
To define the dose-limiting toxicities of this regimen in these patients. (Phase I)
To determine the local control in patients treated at the MTD (determined in phase I). (Phase II)
To compare the disease-free survival and time to progression in these patients with that of historical controls. (Phase II)

OUTLINE: This is a multicenter phase I, dose-escalation study of intensity-modulated radiotherapy, followed by a phase II study.

Induction chemotherapy: Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo CT scan. Patients with no evidence of metastatic disease proceed to chemoradiotherapy.
Chemoradiotherapy: Beginning 1-2 weeks after completion of induction chemotherapy, patients undergo intensity-modulated radiotherapy once daily 5 days a week and gemcitabine hydrochloride IV over 30 minutes once weekly for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients whose disease remains unresectable proceed to adjuvant chemotherapy.
Adjuvant chemotherapy: Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive gemcitabine hydrochloride as in induction chemotherapy.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Conditions studied

Pancreatic Cancer

Browse trials for

Pancreatic Neoplasms 3,235

Keywords

adenocarcinoma of the pancreas
stage III pancreatic cancer

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 8 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

DISEASE CHARACTERISTICS:

Pathologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas, ampulla of Vater, or distal bile duct
- Locally advanced disease
- Medically inoperable, unresectable, or borderline resectable disease
  - No previously resected disease (i.e., status post-pancreaticoduodenotomy)
No non-adenocarcinoma, adenosquamous carcinoma, islet cell carcinoma, cyst adenoma, cystadenocarcinoma, carcinoid tumor, or duodenal carcinoma
No lesions in the tail of the pancreas and/or splenic artery/vein involvement/encasement
No recurrent or metastatic (M1) disease

PATIENT CHARACTERISTICS:

Karnofsky performance status 60-100%
WBC > 3,000/μL
Platelet count > 100,000/μL
Bilirubin ≤ 2 mg/dL
SGOT \< 5 times upper limit of normal (ULN)
Creatinine \< 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Adequate oral nutrition (e.g., ≥ 1,500 calories/day, stable weight for ≥ 2 weeks, and ≤ 5% weight loss)
No active malignancy within the past 3 years, except cervical carcinoma in situ or nonmelanoma skin cancer that has been removed
No severe, active comorbidity, including any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within the past month or precluding study therapy at the time of study registration
- Active hepatitis, decompensated cirrhosis, or clinically significant liver failure
- Other severe comorbid condition, as determined by the principal investigator

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior chemotherapy
No prior radiotherapy to any upper abdominal site
No concurrent prophylactic colony-stimulating factors during radiotherapy
No concurrent warfarin
No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, surgery for cancer, or experimental therapy

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 8 participants (actual)

Study arms

Experimental
Radiotherapy plus gemcitabine
Drug: gemcitabine hydrochloride Radiation: intensity-modulated radiation therapy
Drug: gemcitabine hydrochloride · Radiation: intensity-modulated radiation therapy

Interventions

Druggemcitabine hydrochloride
Pre-Chemoradiation (Induction) Chemotherapy Gemcitabine will be given weekly for seven doses at a dose of 1000 mg/m2/wk (Days 1, 8, 15, 22, 29, 36, 43) unless toxicity develops. Chemoradiation gemcitabine will be given 400 mg/m2, infused over 30 minutes, within 120 minutes before radiotherapy. Post-chemoradiation chemotherapy, patients will receive two cycles of gemcitabine. A cycle will be defined as three weeks of gemcitabine at 1000 mg/m2/d, once weekly, followed by a one-week rest.
Radiationintensity-modulated radiation therapy
Dose escalation levels (cohorts) for this study: Dose Level 1: GTV plus drainage areas 45 Gy, Boost GTV 50.4 Gy Dose Level 2: GTV plus drainage areas 45 Gy, Boost GTV 54.0 Gy Dose Level 3: GTV plus drainage areas 45 Gy, Boost GTV 59.4 Gy Dose Level 4: GTV plus drainage areas 45 Gy, Boost GTV 64.8 Gy Dose Level 5: GTV plus drainage areas 45 Gy, Boost GTV 70.2 Gy

What researchers measure

Primary outcomes

Maximum tolerated dose of intensity-modulated radiotherapy (Phase I)
Time frame: 4 years
Overall survival (Phase II)
Time frame: 4 years
Disease-free survival (Phase II)
Time frame: 4 years

Study locations

1 site

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00878657
Lead sponsor: Rutgers, The State University of New Jersey
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Apr 9, 2009
Start date: Apr 2009
Primary completion: Oct 2012
Completion: Oct 2013
Last update: May 5, 2014

Study contacts

Salma Jabbour, MD

principal investigator · Rutgers Cancer Institute of New Jersey

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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