Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer

NCT00761345 | Completed Phase 1 Results DMC

• 2 other identifiers: FER-GI-021OSI4485s
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

People with pancreatic cancer usually have a large amount of the cancer in the area of the pancreas and around it when they are diagnosed with it. Or their cancer has spread (metastasized)outside that area of the abdomen and is not able to be surgically removed (resected). For patients with metastatic disease, one standard treatment is the combination of gemcitabine and erlotinib. This combination has shown slightly longer survival compared to getting gemcitabine alone. For patients with localized but unresectable disease, the standard treatment remains controversial. Early studies showed that chemotherapy and radiation together was better than either one used alone. The greatest benefit of external beam radiotherapy may be after a period of full-dose chemotherapy alone, to help the rapid spread. A problem of beginning treatment with standard radiotherapy is that the doses of chemotherapy usually have to be reduced sometimes by half. Studies have already shown that low dose radiotherapy (LDRT)is safe. This study will evaluate the safety of LDRT instead of standard doses with full dosing of gemcitabine and erlotinib in patients with locally advanced or limited metastatic pancreatic cancer. Patients will be enrolled in groups of 3 to 6 each with a slightly higher dose of LDRT and erlotinib. For patients with locally advanced disease, this protocol also may help because most patients develop and die from spread to the liver and abdominal cavity.

Conditions

Pancreatic Carcinoma Non-resectable; Metastatic Pancreatic Cancer

Keywords

pancreatic cancer; locally advanced; unresectable; metastatic pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• To Determine the Dose Limiting Toxicities

  weekly physician and nurse assessment and in between as needed until 30 days after treatment termination

Secondary Outcomes (1)

• To Measure Progression Free Survival and Overall Survival

  Evaluate CT scans after every 2 cycles of therapy (about every 6 weeks) and long term follow up every 3 months once off treatment for survival

Study Arms (1)

radiotherapy and chemotherapy

EXPERIMENTAL

gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle

Drug: gemcitabine; Drug: Erlotinib; Radiation: low dose fractionated radiotherapy

Interventions

gemcitabine DRUG

gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.

Also known as: Gemzar

radiotherapy and chemotherapy

Erlotinib DRUG

Erlotinib 100mg or 150mg daily of each 21 day cycle

Also known as: Tarceva

radiotherapy and chemotherapy

low dose fractionated radiotherapy RADIATION

low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle

radiotherapy and chemotherapy

Eligibility Criteria

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

You may qualify if:

• Patients must have a diagnosis of adenocarcinoma of the pancreas that is not amenable to curative surgical resection. Patients with locally advanced unresectable disease and those patients with metastatic disease that can be encompassed in the radiation fields for this study (as assessed by treating radiation oncologist) are eligible.
• Patients may not have received any prior chemotherapy for locally advanced or metastatic pancreatic cancer. Prior adjuvant chemotherapy completed \>1 year previously is allowed.
• Patients must be able to provide informed consent and HIPAA consent.
• Patients must be ≥18 years of age
• Adequate hematologic and organ function:
• ANC ≥ 1,000/μL, platelets ≥ 100,000/μL, hemoglobin ≥ 9.0/dL
• Bilirubin: ≤1.5X ULN
• ALT/AST \< 3.0 X upper limit of normal
• Serum Creatinine: WNL
• Albumin \> 2.5 g/dL
• Measurable and non-measurable disease are permitted
• ECOG performance status 0-1
• Patients must be able to swallow oral medications
• Patients must be able to comply with study and follow up procedures

You may not qualify if:

• No prior radiation therapy to the abdomen.
• Patients must not have any other active illness (e.g. active/uncontrolled infection, uncontrolled cardiac disease, etc.) that would preclude safe therapy in the judgment of the treating physicians. Patients may be enrolled while still on antibiotics as long as clinical signs of active infection are absent.
• Patients with concurrent active malignancy requiring therapy are not eligible. Patients with a history of malignancy within any timeframe not requiring ongoing therapy are eligible.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (3)

Karmanos Cancer Institue

Detroit, Michigan, 48201, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Reading Medical Center

West Reading, Pennsylvania, 19611, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Erlotinib Hydrochloride

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; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Steven J. Cohen
• Organization: Fox Chase Cancer Center

steven.cohen@fccc.edu

215-728-4300

Study Officials

• Steven Cohen, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: September 26, 2008
• First Posted: September 29, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 7, 2017
• Results First Posted: March 31, 2016

Record last verified: 2017-01

Locations

US (3)