Lenalidomide With Gemcitabine in Treatment of Untreated Advanced Carcinoma of the Pancreas
Information source: Sarah Cannon Research Institute
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Pancreatic Cancer
Intervention: Lenalidomide (Drug); Gemcitabine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Sarah Cannon Research Institute Official(s) and/or principal investigator(s):
Jeffrey R Infante, M.D., Study Chair, Affiliation: SCRI Oncology Research Consortium
Overall contact:
Jeffrey R Infante, M.D., Phone: (615) 329-7274, Email: jinfante@tnonc.com
Summary
Because the activity of lenalidomide addresses numerous mechanisms of carcinoma growth
inhibition - including, but not limited to anti-angiogenesis - lenalidomide is being
evaluated as part of induction chemotherapy regimens for solid tumors. This phase II study
in previously untreated metastatic pancreatic cancer is designed to establish and test the
appropriate lenalidomide dose and regimen in combination with gemcitabine.
Clinical Details
Official title: A Phase II Study of Lenalidomide in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To confirm the safety and tolerability (during the lead-in portion of the study) of gemcitabine in combination with lenalidomide based on the incidence of dose-limiting toxicities (DLTs) in patients with advanced pancreatic carcinoma.To explore the anti-tumor activity of the combination of lenalidomide given on Days 1-21 and gemcitabine given on Days 1, 8, and 15 every 28 days in patients with advanced pancreatic carcinoma.
Secondary outcome: To evaluate the response rate, duration of response, progression-free survival (PFS), overall survival, safety, and pain score of the combination of lenalidomide and gemcitabine in patients with advanced pancreatic carcinoma.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Understand and voluntarily sign the informed consent form.
2. Patients >=18 years of age at the time of signing the informed consent form.
3. Ability to adhere to the study visit schedule and other protocol requirements.
4. Histological or cytological documentation of adenocarcinoma of the pancreas, with
metastases not amenable to curative surgery or definitive radiation. Patients with
locally advanced disease are not eligible.
5. Radiographic or clinical evidence of measurable advanced metastatic pancreatic
carcinoma. Patients must have measurable disease according to the international
criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) for
target lesions.
6. Previous gemcitabine or 5-fluorouracil (5-FU) with radiation therapy as adjuvant
therapy is permitted. Extended use of gemcitabine or 5-FU after completion of
adjuvant radiation therapy is not permitted. No prior gemcitabine for metastatic
disease or for primary treatment of locally advanced disease is allowed.
7. ECOG performance status of <=2 at study entry.
8. Laboratory test results within these ranges:
- Absolute neutrophil count (ANC) ≥1,500 cells/mm3 (1. 5 x 109/L)
- Platelet count ≥100,000 cells/ mm3 (100 x 109/L)
- Serum creatinine <=2. 5 mg/dL
- Total bilirubin <=2. 0 mg/dL
- AST (SGOT) and ALT (SGPT) <=3. 0 x ULN or <=5 x ULN if hepatic metastases are
present.
9. Prior history of malignancy (except basal cell or squamous cell carcinoma or
carcinoma in situ of the cervix or breast, or localized prostate cancer with PSA <1. 0
ng/mL), unless the patient has been free of disease for >=3 years.
10. All study participants must be registered into the mandatory RevAssist® program, and
must be willing and able to comply with the requirements of RevAssist®.
11. Females of childbearing potential (FCBP)† must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to,
and again within 24 hours of prescribing lenalidomide (prescriptions must be filled
within 7 days), and must either commit to continued abstinence from heterosexual
intercourse or begin TWO acceptable methods of birth control, one highly effective
method and one additional effective method AT THE SAME TIME, at least 28 days before
she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
Men must agree to use a latex condom during sexual contact with a FCBP even if they
have had a successful vasectomy.
12. Able to take aspirin (81 mg or 325 mg) daily as prophylactic anticoagulation
(patients intolerant to ASA may use warfarin or low molecular weight heparin).
13. Life expectancy of >12 weeks.
14. Ability to swallow intact whole capsules.
Exclusion Criteria:
1. Prior use of systemic therapy for the treatment of adenocarcinoma of the pancreas,
with the exception of 5-fluorouracil or gemcitabine as a radiosensitizer in the
adjuvant setting.
2. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the patient from signing the informed consent form.
3. Pregnant or breast feeding females (lactating females must agree not to breast feed
while taking lenalidomide).
4. Any condition, including the presence of laboratory abnormalities, which places the
patient at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.
5. Surgery or radiation therapy within 14 days of study enrollment as outlined below.
- Surgery within 14 days of the start of study (patients must have recovered from
effects of surgery; 7 days may be considered for minor procedures).
- Palliative radiation therapy within 14 days of the start of study. The
radiation therapy may not be to the only site of measurable disease.
6. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in
case of clinical suspicion of central nervous system involvement).
7. Neuropathy of ≥ grade 2.
8. Known chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus
(HBV), and/or Hepatitis C Virus (HCV).
9. Use of any standard / experimental anti-cancer drug therapy within 28 days of the
initiation of study drug therapy.
10. Patients with a history of or active DVT or PE that are not therapeutically managed
on a stable dose of appropriate anticoagulant.
11. New York Heart Association classification III or IV.
12. Known hypersensitivity to thalidomide.
13. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.
14. Any prior use of lenalidomide.
15. Concurrent use of other anti-cancer agents or treatments.
Locations and Contacts
Jeffrey R Infante, M.D., Phone: (615) 329-7274, Email: jinfante@tnonc.com
Florida Cancer Specialists, Fort Myers, Florida 33901, United States; Not yet recruiting
Watson Clinic Center for Cancer Care and Research, Lakeland, Florida 33805, United States; Not yet recruiting
Oncology Hematology Care, Cincinnati, Ohio 45242, United States; Not yet recruiting
Research Program Coordinator, Phone: 513-891-4800, Email: contact@ohcmail.com
South Carolina Oncology Associates, PA, Columbia, South Carolina 29210, United States; Not yet recruiting
Tennessee Oncology, PLLC, Nashville, Tennessee 37023, United States; Recruiting
Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee 37404, United States; Not yet recruiting
Virginia Cancer Institute, Richmond, Virginia 23235, United States; Not yet recruiting
Additional Information
Starting date: February 2009
Ending date: April 2010
Last updated: May 19, 2009
|
