Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial Of Induction Gemcitabine/CPT-11 Followed By Twice-Weekly Infusion Gemcitabine And Concurrent External Beam Radiation For The Treatment Of Locally Advanced Pancreatic Cancer |
| Study Start Date: | November 2001 |
OBJECTIVES:
- Determine the time to progression, local control, and survival of patients with locally advanced, unresectable pancreatic cancer treated with induction gemcitabine and irinotecan followed by gemcitabine and concurrent radiotherapy.
OUTLINE: Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Within 2 weeks of completing induction chemotherapy, patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. Patients undergo concurrent radiotherapy 5 days a week for 5.5 weeks.
Patients are followed every 8 weeks for 6 months and then every 3 months for 1.5 years.
PROJECTED ACCRUAL: Approximately 60-120 patients will be accrued for this study within 1-2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced pancreatic cancer
- Regional (peri-pancreatic) lymph node involvement allowed
- Clinically or surgically staged and considered unresectable or inoperable
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 6 months
Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Hemoglobin at least 10 g/dL
- Platelet count at least 100,000/mm3
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- Not pregnant
- Fertile patients must use effective contraception
- No other concurrent or prior malignancy within the past 2 years except nonmelanoma skin cancer or in situ carcinoma of the cervix or breast
- No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival to less than 2 years
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent anticancer immunotherapy
Chemotherapy:
- No prior chemotherapy
- No other concurrent anticancer chemotherapy
Endocrine therapy:
- No concurrent anticancer hormonal therapy
Radiotherapy:
- No prior abdominal-pelvic radiotherapy
- No other concurrent anticancer radiotherapy
Surgery:
- See Disease Characteristics
- At least 3 weeks since prior open abdominal surgery
- More than 10 days since prior laparoscopy
Other:
- No other concurrent investigational drug
- No concurrent participation in other clinical study
Contacts and Locations| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Southeastern Medical Oncology Center | |
| Goldsboro, North Carolina, United States, 27534 | |
| East Carolina University School of Medicine | |
| Greenville, North Carolina, United States, 27858-4354 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Greenville Hospital System | |
| Greenville, South Carolina, United States, 29605 | |
| Spartanburg Regional Healthcare System | |
| Spartanburg, South Carolina, United States, 29303 | |
| Study Chair: | Arthur William Blackstock, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00025168 History of Changes |
| Other Study ID Numbers: | CDR0000068933, CCCWFU-57100, NCI-5332 |
| Study First Received: | October 11, 2001 |
| Last Updated: | August 20, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Wake Forest University Baptist Medical Center:
|
stage III pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Irinotecan Camptothecin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013