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Phase II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin as First Line Treatment in Patients With Locally Advanced (Stage IIIB With Malignant Pleural Effusion or Pericardial Effusion) or Metastatic (Stage IV) Non-squamous Non Small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Non-squamous Non Small Cell Lung Cancer

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Trial Information

Phase II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin as First Line Treatment in Patients With Locally Advanced (Stage IIIB With Malignant Pleural Effusion or Pericardial Effusion) or Metastatic (Stage IV) Non-squamous Non Small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



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

- Histologically or cytologically confirmed diagnosis of non-squamous non small cell
lung cancer (NSCLC), not amenable for radical resection, stage IIIB with pleural or
pericardial effusion or stage IV, who has not received previous chemotherapy or other
systemic treatment

- At least one unidimensionally measurable lesion according to the Response Evaluation
Criteria in Solid Tumors (RECIST)

- Male or female patients aged at least 18 years

- ECOG Performance Status (PS): 0-1

- Life expectancy > 3 months

- Prior local radiotherapy is allowed if it was completed ≥ 3 weeks prior to the first
dose of the study medication

- Concomitant palliative radiotherapy to an existing bone lesion for pain control is
allowed

- Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose
of study medication and patient should be fully recovered

- Adequate organ function, including the following:

- Bone marrow: white blood cell (WBC) count >= 4 x 109/L, absolute neutrophil count
(ANC) >= 1.5 x 109/L, platelet count >= 100 x 109/L, hemoglobin >= 9 g/dL

- Hepatic: Bilirubin ≤ 1.5 x the upper limit of normal (ULN), aspartate transaminases
(AST/SGOT) and alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if liver
metastases are present), INR ≤ 1.5 x ULN, albumin >= 3.0 g/dL

- Renal: Serum creatinine ≤ 1.5 mg/dL or creatinine clearance >= 45 mL/min (calculated
according to the Cockroft and Gault formula)

- 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"

- 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

- Ability to cooperate with the treatment and follow-up

Exclusion Criteria:

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

- Histology of pure bronchioloalveolar carcinoma or neuroendocrine features in the
tumor sample

- Previous treatment with chemotherapy, new biological therapies (small molecules,
antibodies), immunotherapy

- Absence of measurable lesions

- 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

- 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)

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

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

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

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

- Known HIV, HBV, HCV infection

- Presence of symptomatic brain metastasis. Patients with brain metastases must:

- Have stable neurologic status following local therapy (surgery or radiation) for at
least 2 weeks after completion of the definitive therapy.

- Be without neurologic dysfunction that would confound the evaluation of neurologic
and other AEs

- Inability or unwillingness to take folic acid, vitamin B12 or corticosteroids

- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other
than aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for
long-acting agents, such piroxicam)

- Significant weight loss (>= 10% body weight during preceding 6 weeks)

- Presence of clinically significant (by physical exam) third space fluid collections,
e.g., ascites or pleural effusions that cannot be controlled by drainage or other
procedures prior to study entry

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary efficacy endpoint is Progression free survival, analyzed in the treated population. PFS is assessed from randomization until either tumor progression, as per RECIST criteria, or until death due to any reason.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CBP08-02

NCT ID:

NCT00942825

Start Date:

April 2009

Completion Date:

November 2012

Related Keywords:

  • Metastatic Non-squamous Non Small Cell Lung Cancer
  • NSCL
  • non-squamous non small cell lung cancer
  • Lung Cancer
  • Lung
  • non-squamous
  • metastatic
  • pleural effusion
  • Stage IIIb
  • Stage IV
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pericardial Effusion
  • Pleural Effusion
  • Pleural Effusion, Malignant

Name

Location

Nevada Cancer InstituteLas Vegas, Nevada  89135
Mary Crowley Cancer Research CentersDallas, Texas  75201
Penn State Cancer InstituteHershey, Pennsylvania  17033