Combination Chemotherapy in Treating Patients With Advanced Cancer of the Pancreas

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

fluorouracil

leucovorin calcium

trimetrexate glucuronate

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven advanced pancreatic cancer with metastatic disease Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT, SGPT and alkaline phosphatase less than 3 times upper limit of normal Serum albumin at least 3.0 g/dL Renal: Serum creatinine no greater than 1.5 mg/dL Other: Not eligible for higher priority protocol No prior malignancy within 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective birth control No underlying medical condition precluding treatment PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy No prior radiotherapy to only site(s) of measurable disease Fully recovered from therapy Surgery: Fully recovered from prior surgery

Sites / Locations

USC/Norris Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002955

First Posted

November 1, 1999

Last Updated

May 20, 2014

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00002955

Brief Title

Combination Chemotherapy in Treating Patients With Advanced Cancer of the Pancreas

Official Title

Modulation of 5-Fluorouracil With Trimetrexate and Leucovorin in Advanced Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

August 1995 (undefined)

Primary Completion Date

May 2000 (Actual)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with advanced cancer of the pancreas.

Detailed Description

OBJECTIVES: I. Evaluate tumor response to a trimetrexate, fluorouracil and leucovorin regimen in patients with advanced pancreatic carcinoma. II. Evaluate the toxicities associated with this regimen in patients with metastatic carcinoma of the pancreas. OUTLINE: The treatment plan consists of an IV infusion of trimetrexate, followed 24 hours later by IV infusions of leucovorin and fluorouracil. After another 24 hours oral leucovorin will be given every 6 hours for 7 doses. A treatment cycle consists of the regimen repeated weekly for 6 weeks followed by 2 weeks of rest. Treatment cycles will be repeated until disease progression or unacceptable toxicity. PROJECTED ACCRUAL: If 3 or more complete or partial responses are observed in the first 22 patients, an additional 11 patients may be accrued for a maximum of 33.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

stage IV pancreatic cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Intervention Type

Drug

Intervention Name(s)

leucovorin calcium

Intervention Type

Drug

Intervention Name(s)

trimetrexate glucuronate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced pancreatic cancer with metastatic disease Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT, SGPT and alkaline phosphatase less than 3 times upper limit of normal Serum albumin at least 3.0 g/dL Renal: Serum creatinine no greater than 1.5 mg/dL Other: Not eligible for higher priority protocol No prior malignancy within 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective birth control No underlying medical condition precluding treatment PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy No prior radiotherapy to only site(s) of measurable disease Fully recovered from therapy Surgery: Fully recovered from prior surgery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Agustin Garcia, MD

Organizational Affiliation

University of Southern California

Official's Role

Study Chair

Facility Information:

Facility Name

USC/Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033-0800

Country

United States

12. IPD Sharing Statement

Citations:

Citation

Garcia AA, Leichman L, Baranda J, et al.: Phase II study of trimetrexate (neutrexin), 5-fluorouracil and leucovorin (NFL) in advacne pancreatic. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A971, 253a, 1999.

Results Reference

result

Pancreatic Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial