Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

NCT00089024 | Completed Phase 2 Results DMC

• 2 other identifiers: 0035-04-FBP30CA036727
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients who may undergo surgery for locally advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Surgical Exploration

  Patients who completed chemotherapy \& chemo-radiation had restaging imaging studies 4 weeks after completion of chemo-radiation. If there were no contraindications for surgical resection, surgical exploration was performed 6-8 weeks after completing chemo-radiation

  After 6 weeks of chemotherapy and then after 4 weeks of chemo-radiation.

• Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment

  Toxicity event collected during Induction chemotherapy (CT) - two 3-week cycles, Concurrent CT and Radiation Therapy (CRT) (approximately 5.5 weeks), post CRT (4 weeks after the end of CRT), 2-3 months post CRT (8-12 weeks after the end of CRT)

  From time of first dose until 30 days following final treatment, approximately 24 weeks

Study Arms (1)

treatment

EXPERIMENTAL

see interventions

Drug: fluorouracil; Drug: gemcitabine hydrochloride; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: adjuvant therapy; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy

Interventions

fluorouracil DRUG

2700 mg/m5 IV over 24 hr after gemcitabine weeks 1 \& 2; Repeat one 3-week cycle starting day 22

Also known as: Tolak, Fluoroplex, Carac

treatment

gemcitabine hydrochloride DRUG

750 (females) or 900 (males) mg/m5 IV over 30 min (day 2)weeks 1 \& 2; Repeat one 3-week cycle starting day 22

Also known as: Gemzar

treatment

leucovorin calcium DRUG

20 mg/m5 PO (day 1) and 20 mg/m5 IV (day 2) weeks 1 and 2; Repeat one 3-week cycle starting day 22

Also known as: folic acid analog

treatment

oxaliplatin DRUG

48 mg/m5 IV over 2 hr weeks 1, 2, 4, and 5

Also known as: chemotherapy

treatment

adjuvant therapy PROCEDURE

Patients who have undergone surgical resection, after post-operative recovery, will receive two additional cycles of gemcitabine/5-FU/leucovorin. Patients will then be followed at 3 month intervals with a history and physical exam, CT scan of the chest/abdomen/pelvis, and tumor markers. If surgical resection is not possible, patients with stable or responsive disease will resume gemcitabine/5-FU/leucovorin and continue on it indefinitely until disease progression provided the patient tolerates it and wishes to remain on therapy.

treatment

conventional surgery PROCEDURE

Restaging with repeat imaging studies will be performed four weeks after completion of the chemo-radiation. If no contraindication for surgical resection is identified, resection will be performed six to eight weeks after completing chemoradiation. At the time of surgical resection, an extensive examination of the abdomen will be performed to exclude the presence of metastatic disease. All operations will be performed with curative intent with resection of all gross tumor (ie R0 \[negative margins\] or R1 \[positive microscopic margins\]). Resection of adjacent involved organs or vascular structures will be performed as clinically indicated.

treatment

neoadjuvant therapy PROCEDURE

Eligible patients will receive an initial two cycles of chemotherapy with gemcitabine 750 (females) or 900 (males) mg/m5 over 30 minutes followed by a 24-hour infusion of fluorouracil 2700 mg/m5 on days 2 and 9 of a 21-day cycle . Calcium leucovorin 20 mg/m5 will be given orally on days 1 and 8 and by IV push on days 2 and 9 prior to the 5-FU. A window of -2 up to +7 days will be allowed to start planned cycles of therapy provided all other criteria to restart the new cycle has been met. Patients will require a central venous catheter (Port, Hickman or Groshong catheter) for the administration of 5-FU.

treatment

radiation therapy RADIATION

A re-staging CT scan, which will be obtained as part of the radiation simulation, will be used to assess any possible response to the initial two cycles of chemotherapy. Unless the patient has developed evidence of metastatic disease, chemoradiation will proceed. Patients who required no treatment delays will commence chemoradiation on day 42. If a one-week delay is needed before cycle 2 of neo-adjuvant chemotherapy can be delivered, the patient will begin chemoradiation on day 49 provided treatment-related toxicity has resolved. If cycle 2 could not be given (2 or more week delay for resolution of treatment-related toxicity), then chemoradiation will begin once toxicity has resolved (may be earlier than day 42).

treatment

Eligibility Criteria

• Age: 19 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of adenocarcinoma of the pancreas
• o Locally advanced disease
• Potentially resectable disease
• years of age and over
• Karnofsky 60-100%
• Absolute granulocyte count ≥ 2,000/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin ≤ 2.0 mg/dL (in the absence of biliary obstruction)
• If biliary obstruction is present, patients must undergo biliary decompression
• Bilirubin ≤ 3.0 mg/dL after biliary drainage has been established
• Creatinine ≤ 1.6 mg/dL

You may not qualify if:

• No early stage resectable disease
• No concurrent non-steroidal anti-inflammatory medication
• No evidence of distant metastases to the liver or peritoneal area according to imaging studies and laparoscopic staging
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No serious uncontrolled cardiac arrhythmia
• Not pregnant or nursing
• No uncontrolled illness
• No active or ongoing infection requiring IV antibiotics
• No marked intolerance to 5-fluoropyrimidines (i.e., fluorouracil, floxuridine, capecitabine, or fluorocytosine)
• No allergy to sulfonamides, aspirin, or non-steroidal anti-inflammatory drugs
• No allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with study chemotherapy
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma
• No prior chemotherapy for pancreatic cancer
• No prior abdominal radiotherapy

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Eppley Cancer Center, University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fluorouracil; Gemcitabine; Leucovorin; Folic Acid Antagonists; Oxaliplatin; Drug Therapy; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Coordination Complexes; Organic Chemicals; Therapeutics; Combined Modality Therapy

Results Point of Contact

• Title: Jean L Grem
• Organization: University of Nebraska Medical Center

jgrem@unmc.edu

402-552-3233

Study Officials

• Jean L Grem, MD

  University of Nebraska

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2004
• First Posted: August 5, 2004
• Study Start: February 25, 2004
• Primary Completion: January 22, 2010
• Study Completion: December 1, 2014
• Last Updated: September 29, 2023
• Results First Posted: October 21, 2019

Record last verified: 2023-09

Locations

US (1)