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Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol >30 pg/mL


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Lung Cancer

Thank you

Trial Information

Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol >30 pg/mL


OBJECTIVES:

Primary

- Compare the overall survival of patients with chemotherapy-naïve stage IIIB or IV or
recurrent non-small cell lung cancer treated with paclitaxel poliglumex and carboplatin
vs paclitaxel and carboplatin.

Secondary

- Compare the progression-free survival of women treated with these regimens.

- Compare the disease control in women treated with these regimens.

- Compare the clinical benefit in women treated with these regimens.

- Compare the response rate in women treated with these regimens.

- Compare the quality of life of women treated with these regimens.

- Compare the safety and tolerability in women treated with these regimens.

OUTLINE: This is a multicenter study.

Patients are stratified according to age (≥ 60 vs < 60 years old), geographical location
(United States of America, Canada, or Australia vs the rest of the world), extent of disease
(independent of brain metastases, i.e., brain metastases are not considered in determining
extent of disease) (intrathoracic disease only vs extrathoracic disease), and ECOG
performance status (0 or 1 vs 2). Patients will be randomized to 1 of 2 treatment arms.

- Arm I: Patients receive paclitaxel poliglumex IV over 10 minutes followed by
carboplatin IV over 30 minutes on day 1.

- Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30
minutes on day 1.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course, and at the completion of study
treatment by the Pain Assessment Patient Questionnaire, the Pulmonary Symptom Index, and the
Functional Assessment of Cancer Therapy- Lung Cancer Subscale (FACT-LCS) (only in countries
in which a validated translation is currently available).

After completion of study therapy, patients are followed at least monthly.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer
(NSCLC)

- Cytologic specimens obtained by brushings, washings, or needle aspiration of a
defined lesion or from a pleural effusion are acceptable; sputum cytology alone
is not acceptable for determining cell type

- Must meet one of the following criteria:

- Recurrent disease following completion of radiation or surgery

- Stage IIIB disease and not a candidate for combined modality therapy (primary
radiation therapy or surgery)

- Stage IV disease

- Patients may have either measurable or nonmeasurable disease according to RECIST
criteria

- Baseline estradiol > 30 pg/mL

- Patients on hormone replacement therapy are eligible provided baseline estradiol
> 30 pg/mL

- Patients with known brain metastases must have received standard antitumor treatment
(e.g. whole brain radiation, stereotactic radioablation, or surgery) for their CNS
metastases as defined by the site's institutional standards

- Neurologic function must have been stable for 2 weeks before randomization and
patients must either be off steroid therapy for their brain metastases or on a
tapering regimen

- Patients must have recovered from therapy for their brain metastases with no
evidence of significant unstable neurological symptoms within the 4 weeks before
study randomization

- No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell
histology

PATIENT CHARACTERISTICS:

- Female

- ECOG performance score 0-2

- Life expectancy ≥ 12 weeks

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL (may be achieved with transfusion)

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 times ULN (CTC grade 1) (patients with Gilbert syndrome or
other hereditary bilirubin defects may be included regardless of bilirubin levels)

- SGOT and SGPT ≤ 2.5 times ULN (CTC grade 0 or 1) (5 times ULN [CTC grade 0 to 2] if
due to liver metastases)

- Alkaline phosphatase ≤ 2.5 times ULN except for elevated alkaline phosphatase with
laboratory documentation that demonstrates bone origin

- No pregnant women or nursing mothers

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
participation

- No known hypersensitivity to study drugs or excipients

- Meets all of the following criteria:

- No weight loss > 10% in previous 6 months

- Lactate dehydrogenase (LDH) ≤ 600 IU/L (central laboratory) regardless of weight
loss

- LDH ≤ 400 IU/L (central laboratory) and no weight loss ≥ 5% in previous 6 months

- BMI ≤ 35

- No concurrent primary malignancies except for carcinoma in situ or non-melanoma skin
cancer

- No neuropathy grade 2 or greater

- No clinically significant active infection for which active therapy is underway

- No unstable medical conditions including unstable angina or myocardial infarction
within the past 6 months

- Patients with evidence of cardiac conduction abnormalities are eligible if their
cardiac status is stable

- No circumstance that would preclude completion of the study or the required follow-up

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from major surgery

- At least 7 days since prior local palliative radiotherapy

- At least 30 days since prior radiation therapy with curative intent

- At least 4 weeks since prior investigational therapy, unless local requirements are
more stringent

- No prior systemic chemotherapy for the treatment of lung cancer, including systemic
radiosensitizers used to treat brain metastases or any biologic agents

- No concurrent non-protocol-specified systemic antitumor therapy

- No concurrent amifostine, investigational agents, other cytotoxic agents for this
disease

- No concurrent radiotherapy (with the exception of radiotherapy for brain or bone
metastases for palliative purposes or radiotherapy for a condition other than NSCLC
that was ongoing at the time of randomization)

- Patients receiving palliative radiotherapy (treatment for symptomatic metastatic
disease) may be treated while on study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Fred B. Oldham, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cell Therapeutics

Authority:

Unspecified

Study ID:

CDR0000573340

NCT ID:

NCT00551733

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
New York Medical CollegeValhalla, New York  10595
Virginia Mason Medical CenterSeattle, Washington  98111
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Columbia Comprehensive Cancer Care ClinicColumbia, Missouri  65201
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Hematology Oncology Consultants - NapervilleNaperville, Illinois  60540
Stanford Cancer CenterStanford, California  94305-5824
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Lincoln Medical and Mental Health CenterBronx, New York  10451
Veterans Affairs Medical Center - RenoReno, Nevada  89520
Rush Cancer Institute at Rush University Medical CenterChicago, Illinois  60612
Cancer Centers of the Carolinas - EastsideGreenville, South Carolina  29601
Hattiesburg Clinic, PA at Forrest GeneralHattiesburg, Mississippi  39401
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia FieldsOlympia Fields, Illinois  60461
Broward Oncology AssociatesFt. Lauderdale, Florida  33308
West Michigan Regional Cancer and Blood CenterLudington, Michigan  49431
Las Vegas Cancer CenterLas Vegas, Nevada  89102
Clinical Trials and Research Associates, IncorporatedMontebello, California  90640
Cancer Center of IndianaNew Albany, Indiana  47150
Family Cancer Center, PLLC - ColliervilleCollierville, Tennessee  38077
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California  91505
Southwest Regional Cancer Center - CentralAustin, Texas  78705
Mary Crowley Medical Research Center at Sammons Cancer CenterDallas, Texas  75246
Providence Medical GroupTerre Haute, Indiana  47802
Vita Hematology Oncology at St. Luke's HospitalBethlehem, Pennsylvania  18015
Richmond University Medical CenterStaten Island, New York  10310-1699
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
Family Medicine of Vincennes Clinical Trial CenterVincennes, Indiana  47591
Cancer Outreach Associates - AbingdonAbingdon, Virginia  24211
Lone Star Oncology - AustinAustin, Texas  78759
Mid-South Cancer CenterGermantown, Tennessee  38138
Horizon Institute for Clinical ResearchHollywood, Florida  33021
Scottsdale Medical SpecialistsScottsdale, Arizona  85258
Cell Therapeutics, IncorporatedSeattle, Washington  98119
Southwest Cancer Care - EscondidoEscondido, California  92025-4404
Newland Medical Associates PC - SouthfieldSouthfield, Michigan  48275
Blood and Cancer Center, IncorporatedCanfield, Ohio  44406
Utah Hematology Oncology, PCOgden, Utah  84403