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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 14 July 2014
Main ID:  NCT01276496
Date of registration: 12/01/2011
Primary sponsor: National Cancer Institute (NCI)
Public title: Cilengitide and Paclitaxel in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery
Scientific title: A Phase I, Open Label, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetic Properties of the Combination of Cilengitide and Paclitaxel in Patients With Advanced Solid Malignancies
Date of first enrolment: December 2010
Target sample size: 13
Recruitment status: Active, not recruiting
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
United States
Name:   Julian Molina
Affiliation:  Mayo Clinic
Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologic proof of cancer that is now unresectable (solid tumors, excluding

- For Cohort II only:

- Histologic adenocarcinoma of the breast with manifestations of metastatic cancer
or locally advanced, unresectable cancer

- Estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2)
receptor negative disease per local standards

- Refractory to taxanes which is defined as one of the following:

- Having relapsed during or within 12 months of completing adjuvant paclitaxel or

- Disease progression while on any taxane in the locally advanced, unresectable or
metastatic breast cancer setting

- Ability and willingness to undergo biopsy for biomarker testing prior to start
of treatment

- Disease must be measurable by imaging-based evaluation per Response Evaluation
Criteria in Solid Tumors (RECIST) criteria (v1.1)

- Up to 5 prior regimens of chemotherapy for metastatic disease are allowed

- Absolute neutrophil count (ANC) >= 1500/µL

- Hemoglobin (Hgb) >= 9 g/dL

- Platelets (PLT) >= 100,000/µL

- Total bilirubin =< 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) =< 3 x ULN or AST =< 5 x ULN if liver involvement

- Creatinine =< 1.5 x ULN

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, or 1 (or KPS >

- Ability to provide informed consent

- Willingness to return to the enrolling Mayo Clinic institution for follow-up

- Life expectancy >= 12 weeks

- All patients: Willingness to provide blood samples for the mandatory correlative
research component

- For Cohort II, tissue biopsies are mandatory

- Women of childbearing potential only: Negative serum pregnancy test done =< 7 days
prior to registration, for women of childbearing potential including women within 2
years of post-menopause

Exclusion Criteria:

- Known standard therapy for the patient's disease that is potentially curative or
definitely capable of extending life expectancy

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Any of the following prior therapies:

- Chemotherapy =< 21 days prior to registration

- Mitomycin C/nitrosoureas =< 42 days prior to registration

- Immunotherapy =< 14 days prior to registration

- Biologic therapy =< 14 days prior to registration

- Prior investigational therapy =< 28 days prior to registration

- Full* field radiation therapy =< 28 days prior to registration or limited**
field radiation therapy < 14 days prior to registration

- Full field radiation encompasses the entire area of known disease
involvement and surrounding uninvolved but at-risk areas, e.g. subtotal
nodal (mantle and upper abdomen) or total nodal irradiation

- Limited field radiation is restricted to treating only the known areas of
clinical disease, e.g. involved-field therapy for lymphoma

- Major surgery (i.e., laparotomy) =< 4 weeks prior to registration; minor surgery
=< 2 weeks prior to registration; NOTE: Insertion of a vascular access device is
not considered major or minor surgery in this regard

- Unresolved toxicities from prior therapy with the exception of alopecia that have not
resolved to =< grade 1, unless the patient has a chronic, stable =< grade 2 toxicity
that would not interfere with the evaluation of the study agents

- New York Heart Association classification III or IV

- Central nervous system (CNS) metastases or seizure disorder; Note: CNS metastases are
allowed if previously treated and stable for at least 4 weeks

- Any of the following:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception (condoms, diaphragm, injections, intrauterine device [IUD], or
abstinence, etc.); oral, implantable, or injectable contraceptives may be
affected by cytochrome P450 interactions, and are therefore not considered
effective for this study

- NOTE: This study involves an investigational agent whose genotoxic, mutagenic
and teratogenic effects on the developing fetus and newborn are unknown

- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
considered investigational (utilized for a non-FDA-approved indication and in the
context of a research investigation)

- Co-morbid systemic illnesses or other severe concurrent disease which, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens

- Immunocompromised patients (other than that related to the use of corticosteroids)
including patients known to be HIV positive on HAART therapy as there is a risk for
drug interaction with antiretroviral treatment

- Receiving any other investigational agent which would be considered as a treatment
for the primary neoplasm

- Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Nonmelanotic
skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history of prior
malignancy, they must not be receiving other specific treatment for their cancer

- History of myocardial infarction =< 6 months prior to registration, or congestive
heart failure requiring use of ongoing maintenance therapy for life-threatening
ventricular arrhythmias

- Uncontrolled hypertension, labile hypertension of history of poor compliance with
antihypertensive medication

- Patients with active, bleeding diathesis

- Non-disease related- major surgery, =< 28 days or minor surgery =< 7 days prior to

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: cilengitide
Drug: paclitaxel
Other: laboratory biomarker analysis
Other: pharmacological study
Primary Outcome(s)
Best response, defined to be complete response (CR) or partial response (PR) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Time Frame: From start of the treatment until disease progression/recurrence, assessed up to 3 months]
Change in Cyr61 expression levels (Cohort II) [Time Frame: Baseline to 21 days]
Change in Cyr61 expression levels (Cohort II) [Time Frame: Baseline to up to 3 months]
Incidence of grade 3+ adverse events, as graded using NCI CTCAE v 4.0 [Time Frame: Up to 3 months]
Incidence of hematologic toxicity, including thrombocytopenia, neutropenia, and leukopenia, evaluated via the ordinal CTC [Time Frame: Up to 3 months]
Incidence of non-hematologic toxicity, evaluated via the ordinal Common Toxicity Criteria (CTC) [Time Frame: Up to 3 months]
MTD of cilengitide and paclitaxel, defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients as graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [Time Frame: 3 weeks]
Number of all adverse events, graded according to the NCI CTCAE v4.0 [Time Frame: Up to 3 months]
Overall survival (OS) (Cohort II) [Time Frame: The time of registration to death due to any cause, assessed up to 3 months]
Progression-free survival (PFS) (Cohort II) [Time Frame: The time of registration to documentation of disease event where a disease event is local/regional/distant progression, contralateral breast disease, second primary disease or death due to any cause, assessed up to 3 months]
Response rate, defined as the proportion of patients whose tumor responds to treatment (Cohort II) [Time Frame: Up to 3 months]
Severity of all adverse events, graded according to NCI CTCAE v4.0 [Time Frame: Up to 3 months]
Time to progression [Time Frame: Up to 3 months]
Time to treatment failure [Time Frame: Time from registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 months]
Time until any treatment related toxicity [Time Frame: Up to 3 months]
Time until hematologic nadir for ANC [Time Frame: Up to 3 months]
Time until hematologic nadir for platelets [Time Frame: Up to 3 months]
Time until hematologic nadir for WBC [Time Frame: Up to 3 months]
Time until treatment related grade 3+ toxicity [Time Frame: Up to 3 months]
Secondary Outcome(s)
Incidence of toxicity, as assessed using PRO-CTCAE [Time Frame: Up to 3 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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