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

NCT00878657 | Terminated Phase 1

• 4 other identifiers: CDR0000639635P30CA072720CINJ-0708050220090024
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage III pancreatic cancer

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose of intensity-modulated radiotherapy (Phase I)

  4 years

• Overall survival (Phase II)

  4 years

• Disease-free survival (Phase II)

  4 years

Study Arms (1)

Radiotherapy plus gemcitabine

EXPERIMENTAL

Drug: gemcitabine hydrochloride Radiation: intensity-modulated radiation therapy

Drug: gemcitabine hydrochloride; Radiation: intensity-modulated radiation therapy

Interventions

gemcitabine hydrochloride DRUG

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.

Radiotherapy plus gemcitabine

intensity-modulated radiation therapy RADIATION

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

Radiotherapy plus gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Salma Jabbour, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2013
• Last Updated: May 5, 2014

Record last verified: 2014-05

Locations

US (1)