Pemetrexed, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

NCT00310050 | Terminated Phase 1 Results FDA Drug FDA Device

• 4 other identifiers: CDR0000466320CCCWFU-57103LILLY-H3E-US-X031CCCWFU-BG04-529
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. 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. Radiation therapy uses high energy x-rays to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when given together with radiation therapy in treating patients with locally advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

stage II pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• Determine Maximum Tolerated Dose of Pemetrexed When Administered With Concomitant Radiation Therapy

  42 days

• Quantitative Toxicity of Pemetrexed When Administered With Concomitant Radiation Therapy

  42 days

Secondary Outcomes (4)

• Qualitative Dose-limiting Toxicities of Pemetrexed in Combination With Radiation Therapy

  42 days

• Patterns of Failure

  1 year

• Patterns of Response

  1 year

• Number of Participants That Survived

  1 year

Study Arms (1)

Pemetrexed in combination with concomitant radiotherapy

EXPERIMENTAL

Patients will receive Pemetrexed plus Radiotherapy.

Drug: pemetrexed disodium; Device: Radiotherapy

Interventions

pemetrexed disodium DRUG

500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).

Pemetrexed in combination with concomitant radiotherapy

Radiotherapy DEVICE

During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).

Pemetrexed in combination with concomitant radiotherapy

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed carcinoma arising from the pancreas * Stage II or III disease, meeting 1 of the following criteria: * Nonresectable disease * Potentially resectable disease * Resectable disease * Stage IV disease with symptomatic back pain requiring palliation allowed at the discretion of the principal investigator * Measurable, evaluable, or nonmeasurable disease * No neuroendocrine tumor of the pancreas * No documented brain metastasis * No clinically significant pleural or peritoneal effusions that cannot be drained PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 12 weeks * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver has tumor involvement) * AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement) * Creatinine clearance ≥ 45 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No active infection * No serious systemic disorders that would preclude study treatment * No significant cardiovascular disease in the form of abnormal electrocardiogram coupled with clinical features of recent or recurrent cardiac disease (including myocardial infarction, angina, or hypertension) PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior investigational agents * No prior chemotherapy for pancreatic cancer * Must be able to discontinue aspirin, dexamethasone, and other nonsteroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after pemetrexed disodium dose (5 days before for long-acting agents such as piroxicam) * Must be able and willing to take folic acid and cyanocobalamin (vitamin B12) supplementation

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pemetrexed; 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)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Therapeutics

Results Point of Contact

• Title: Dr. William Blackstock
• Organization: Wake Forest University Health Sciences

ablackst@wakehealth.edu

3367136501

Study Officials

• Arthur William Blackstock, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

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: March 29, 2006
• First Posted: April 3, 2006
• Study Start: October 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: November 30, 2018
• Results First Posted: November 30, 2018

Record last verified: 2018-11

Locations

US (1)