Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer

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Brief Title

Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer

Official Title

Randomized Phase II/III Trial of Paclitaxel Plus Carboplatin With or Without Bevacizumab (NSC #704865) in Patients With Advanced Nonsquamous NSCLC

Brief Summary

      Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they
      stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in
      different ways. Some block the ability of cancer cells to grow and spread. Others find cancer
      cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy
      with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is
      to see if combination chemotherapy works better with or without bevacizumab in treating
      patients who have advanced, metastatic, or recurrent non-small cell lung cance
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To assess toxicity and survival in patients with advanced or metastatic (stage IIIB
      pleural effusion/IV), nonsquamous histology non-small cell lung cancer (NSCLC) treated with
      carboplatin plus paclitaxel +/- bevacizumab. (Phase II) II. To assess response rates and time
      to progression in patients with advanced or metastatic (stage IIIB-pleural effusion/IV),
      nonsquamous histology NSCLC treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase
      II) III. To assess overall survival in patients with advanced or metastatic (stage
      IIIB-pleural effusion/IV), nonsquamous histology NSCLC treated with carboplatin plus
      paclitaxel +/- bevacizumab. (Phase III) IV. To assess response rates, time to progression,
      and toxicity in patients with advanced or metastatic (stage IIIB-pleural effusion/IV),
      non-squamous histology NSCLC treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase
      III)

      SECONDARY OBJECTIVES:

      I. To determine if pre-treatment levels of plasma VEGF predict response to chemotherapy with
      carboplatin-Taxol with or without anti-VEGF monoclonal antibody (MAb).

      II. To determine if pre-treatment plasma VEGF is of prognostic value in advanced NSCLC.

      III. To determine whether elevated plasma levels of endothelial cell-specific proteins (VCAM,
      E-selectin), reflective of chemotherapy or anti-VEGF induced endothelial damage, are useful
      markers in assessing response to carboplatin/Taxol +/- anti-VEGF therapy.

      IV. To determine whether pre- and post-treatment plasma levels of basic fibroblast growth
      factor (bFGF) is of prognostic value or predictive of response to therapy.

      OUTLINE: This is a randomized study. Patients are stratified according to measurable disease
      (yes vs no), prior radiotherapy (yes vs no), weight loss (less than 5% vs 5% or more), and
      disease stage (IIIB vs IV vs recurrent). Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30
      minutes on day 1.

      ARM II: Patients receive paclitaxel and carboplatin as in arm I followed by bevacizumab IV
      over 30-90 minutes on day 1.

      Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease
      progression or unacceptable toxicity.

      After completion of 6 courses, patients in arm II with stable or responding disease continue
      to receive bevacizumab only. Treatment repeats every 3 weeks in the absence of disease
      progression or unacceptable toxicity.

      Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 842 patients will be accrued for this study.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Survival


Condition

Adenocarcinoma of the Lung

Intervention

paclitaxel

Study Arms / Comparison Groups

 Arm I (paclitaxel and carboplatin)
Description:  Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1.
Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

842

Start Date

August 2002


Primary Completion Date

September 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed non-small cell lung
             cancer EXCEPT squamous cell carcinoma; mixed tumors will be categorized by the
             predominant cell type unless small cell elements are present in which case the patient
             is ineligible; cytologic or histologic elements can be established on metastatic tumor
             aspirates or biopsy

          -  Patients must have advanced NSCLC (stage IIIB with malignant pleural effusion or stage
             IV or recurrent disease)

          -  Patients must have measurable or non-measurable disease

          -  ECOG performance status 0 or 1

          -  Patients must not have known central nervous system (CNS) metastases; a head CT is
             required within 4 weeks prior to study entry; (MRIs are also acceptable)

          -  Patients must not have received prior systemic chemotherapy at any time

          -  ANC >= 1500/mm^3

          -  Platelets >= 100,000/mm^3

          -  Total bilirubin =< 1.5 mg/dl

          -  Transaminases =< 5 x ULN

          -  Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN)

          -  Urine dipstick for proteinuria of less than 1+ (i.e., either 0 or trace); if urine
             dipstick is >= 1+ then a 24 hour urine for protein must demonstrate < 500 mg of
             protein in 24 hours to allow participation in the study; note: urinalysis is also
             acceptable

          -  Patients must have INR =< 1.5 and a PTT no greater than upper limits of normal within
             1 week prior to randomization

          -  Pregnant and lactating women are excluded from the study

          -  Women of childbearing potential and sexually active males must agree to use an
             accepted and effective method of contraception (hormonal or barrier methods,
             abstinence) prior to study entry and for the duration of the study

          -  Patients must not have had immuno, hormonal or radiation therapy within 3 weeks prior
             to entering the study; those who have not recovered from adverse events due to agents
             administered more than 3 weeks earlier are ineligible

          -  Patients must not have 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

          -  Patients must have no history of thrombotic or hemorrhagic disorders

          -  Patients with history of hypertension must be well-controlled (< 150/100) on a stable
             regimen of anti-hypertensive therapy

          -  Patients must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or
             nonsteroidal anti-inflammatory agents known to inhibit platelet function; treatment
             with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or
             cilostazol (Pletal) is also not allowed

          -  Patients must not have serious non-healing wound ulcer, or bone fracture, or major
             surgical procedure within 21 days prior to starting treatment

          -  Patients must not be on therapeutic anticoagulation; prophylactic anticoagulation of
             venous access devices is allowed; caution should be taken on treating patients with
             low dose heparin or low molecular weight heparin for DVT prophylaxis during treatment
             with bevacizumab as there may be an increased risk of bleeding

          -  Patients with a history of gross hemoptysis (defined as bright red blood of a 1/2
             teaspoon or more) will be excluded from this trial
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alan Sandler, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00021060

Organization ID

NCI-2012-02947

Secondary IDs

E4599

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Alan Sandler, Principal Investigator, Eastern Cooperative Oncology Group


Verification Date

February 2013