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Randomized Phase III Multicenter Trial of RRM1 & ERCC1 Directed Customized Chemotherapy Versus Standard of Care for 1st Line Treatment of Patients With Advanced Non-Small-Cell Lung Cancer

Phase 3
18 Years
Open (Enrolling)
Non-Small Cell Lung Cancer

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Trial Information

Randomized Phase III Multicenter Trial of RRM1 & ERCC1 Directed Customized Chemotherapy Versus Standard of Care for 1st Line Treatment of Patients With Advanced Non-Small-Cell Lung Cancer

Before each cycle, blood tests, vital signs, interim medical history, and a physical exam
will be performed. Patients will be carefully checked so that immediate intervention can be
initiated should an adverse event (i.e. hypersensitivity) occur.

The last treatment cycle according to the study will be cycle #6, or any earlier cycle.
Certain tests will be done within 28 days after the last drug infusion. These include
physical exam, vital signs, temperature, weight, adverse event evaluation, imaging studies,
and blood work.

The study doctor will see the participants every 6 to 8 weeks for at least 12 months after
they start treatment. After that, the participants will be followed every 3 months for an
additional 24 months.

Inclusion Criteria:

- Histologically confirmed Non-Small Cell Lung Cancer (NSCLC) of adenocarcinoma,
squamous cell carcinoma, large cell carcinoma, or NSCLC not otherwise specified.
Patients with suspected NSCLC may enroll prior to the diagnostic biopsy in order to
obtain both the diagnostic and molecular analysis-required specimen during the same
procedure. Must have blood work within 30 days prior to biopsy to eliminate any
unnecessary biopsies on patients that do not qualify (screen failures) due to
laboratory values that do not meet the inclusion/exclusion criteria. If a patient
has blood work obtained at an outside facility, this can be utilized for the
preliminary assessment prior to biopsy, but final inclusion/exclusion values must be
obtained within 14 days of start of treatment.

- Willing to undergo biopsy to enable customization of chemotherapy

- Stage IV or IIIB (malignant pleural effusion) NSCLC

- Measurable or evaluable disease by Response Evaluation Criteria In Solid Tumors

- Performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria

- Adequate bone marrow function as evidenced by the following (assessed within 14 days
of starting treatment): Absolute neutrophil count >= 1,500/mm³, Platelet count >=
100,000/mm³, Hemoglobin >= 8.0 gm/dL

- Prothrombin time (PT) and activated prothrombin time with thromboplastin and kaolin
(APTT) within normal laboratory ranges

- Serum creatinine <= 1.5 x upper limit of normal (ULN) assessed within 14 days of
starting treatment

- Adequate liver function as evidenced by the following (assessed within 14 days of
starting treatment): Total bilirubin must be within normal limits; aspartic
transaminase (AST) and alanine transaminase (ALT) <= 2.5 x ULN with a normal alkaline
phosphatases; alkaline phosphatases <= 4 x upper limit of normal with normal AST and
ALT; patients with elevations of alk phos and AST and/or ALT will be excluded

- Serum calcium <= 1.1 x ULN

- Signed informed consent document

- Women of childbearing potential must have a negative pregnancy test. Men with
partners in the childbearing age group and women of childbearing potential must use
effective contraception while on treatment and for 6 months thereafter.

- Previous surgery for NSCLC (more that 30 days before study entry)

- Previous radiotherapy (RT) is allowed if: the time between completion of RT and
initiation of chemotherapy is at least 7 days; the patient has fully recovered from
all toxic effects; at least one target lesion or evaluable disease is outside the
radiation field

- Previous chemotherapy allowed if the last dose was administered equal to or greater
than 12 months ago. This chemotherapy must have been given in an adjuvant or
neoadjuvant mode prior to or after a complete surgical resection (R0 resection) for a

- Patients with stable brain metastases will be allowed to enroll. Stable brain
metastases being defined as no progression of brain metastases 28 days after
conclusion of definitive treatment as documented by a computed tomography (CT) scan
or magnetic resonance imaging (MRI) of the brain. Patients with incidentally
discovered asymptomatic brain metastases may be enrolled and treated with
chemotherapy without prior brain irradiation if deemed feasible by the treating

Exclusion Criteria:

- Pregnant or lactating

- Prior systemic chemotherapy or immunotherapy for advanced NSCLC.

- Prior malignancies, except: cured non-melanoma skin cancer curatively treated in situ
carcinoma of the cervix any other curatively treated malignancy with no evidence of
disease recurrence for at least 3 years

- Presence of uncontrolled brain or leptomeningeal metastases

- Peripheral neuropathy or hearing loss of neural origin equal to or greater than grade
2 by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 except if due to

- Other serious illness or medical condition, including but not limited to:

congestive heart failure myocardial infarction within 6 months significant neurologic or
psychiatric disorders that would impact study participation as judged by the treating
physician or study chair infection requiring intravenous (IV) antibiotics tuberculosis
with ongoing therapy at study entry superior vena cava syndrome, except if controlled with
radiation active peptic ulcer disease uncontrolled diabetes mellitus as judged by the
treating oncologist any contraindication to high dose corticosteroid therapy such as
herpes simplex, herpes zoster, hepatitis, or other disease

- Hypercalcemia requiring therapeutic intervention

- Clinically significant ascites and/or pericardial effusion

- Patients with a history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 80

- Concurrent treatment with other investigational drugs

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Progression Free Survival (PFS)

Outcome Description:

The primary endpoint is PFS at 6 months (determined from the date of randomization). The anticipated 6-month PFS in arm B is 38% (median PFS 0 of 4.3 months), and the goal in the experimental arm is to achieve a 33% improvement to 50% at 6 months (median PFS of 6.0 months).

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Charles Williams, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

June 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • RRM1
  • ERCC1
  • Customized Chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Leesburg Regional Medical Center Leesburg, Florida  34748
Southeast Nebraska Cancer Center Lincoln, Nebraska  68510
Center for Cancer Care & Research/Watson Lakeland, Florida  33805
Johns Hopkins Sidney Kimmell Comprehensive Cancer Center Baltimore, Maryland  21231