Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II)



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:May 2008
End Date:November 2012

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Phase I/II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin in Patients With Advanced Solid Tumors and in Chemotherapy-naïve Patients With Malignant Pleural Mesothelioma

The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined
with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid
malignancy that is metastatic or unresectable and for which standard curative or palliative
measures do not exist or are no longer effective or would otherwise be eligible for cisplatin
and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined
based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet
combination will be assessed during the phase I part of the trial.

The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at
the MTD determined in the phase I part) in previously untreated, unresectable malignant
pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed,
cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be
stratified according to histology and performance status.


Inclusion Criteria:

1. Signed informed consent obtained prior to initiation of any study-specific procedures

2. Phase I: Histologically confirmed solid malignancy that is metastatic or unresectable
and for which standard curative or palliative measures do not exist or are no longer
effective or would otherwise be eligible for cisplatin and pemetrexed as first-line
therapy

Phase II: Histologically or cytologically confirmed diagnosis of malignant pleural
mesothelioma (MPM), not amenable for radical resection, who has not received previous
chemotherapy or other systemic treatment

3. Measurable disease according to the modified Response Evaluation Criteria in Solid
Tumors (RECIST, see below)

4. Male or female patients aged at least 18 years

5. ECOG Performance Status (PS): 0-2

6. Previous anticancer treatment must be discontinued at least 3 weeks prior to first
dose of study treatment (6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if
discontinued prior to treatment initiation, with the exception of 8 weeks for
bicalutamide)

7. Life expectancy greater than 3 months

8. Adequate organ function

9. Female patients of child-bearing potential must have a negative pregnancy test and be
using at least one form of contraception as approved by the Investigator for 4 weeks
prior to the study and 4 months after the last dose of study drug. For the purposes of
this study, child-bearing potential is defined as: "All female patients unless they
are post-menopausal for at least one year or are surgically sterile"

10. Male patients must use a form of barrier contraception approved by the investigator
during the study and for 4 months after the last dose of study drug

11. Ability to cooperate with the treatment and follow-up

Exclusion Criteria:

1. Radiation therapy to more than 30% of the bone marrow prior to entry into the study

2. Phase II only: Mesothelioma originating outside the pleura (e.g.: peritoneum)

3. Absence of measurable lesions

4. The patient has an ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia,
uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled
medical disorders in the opinion of the investigator.

5. Any previous history of another malignancy within 5 years of study entry (other than
cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix)

6. Presence of any significant central nervous system or psychiatric disorder(s) that
would hamper the patient's compliance

7. Evidence of peripheral neuropathy > grade 1 according to NCI-CTCAE Version 3

8. Treatment with any other investigational agent, or participation in another clinical
trial within 28 days prior to study entry

9. Pregnant or breast-feeding patients or any patient with childbearing potential not
using adequate contraception

10. Known HIV, HBV, HCV infection

11. Presence of CNS metastases
We found this trial at
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Duarte, California 91010
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Detroit, MI
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Las Vegas, Nevada 89135
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Salt Lake City, Utah 84112
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San Antonio, Texas 78229
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Scottsdale, Arizona 85259
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Tucson, Arizona
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