Clinical trial · Interventional

Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

A Randomized, Phase III Multicenter Trial Of Gemcitabine In Combination With Carboplatin Or Paclitaxel Plus Carboplatin In Patients With Metastatic (Stage IIIB, IV) Non-Small Cell Lung Cancer

NCT00054392CI-TRIAL-00011323withdrawnPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Not opened at Fox Chase Cancer Center

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy such as gemcitabine, carboplatin, and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
carboplatin	Drug	Carboplatin	ALIAS
gemcitabine hydrochloride	Drug	Gemcitabine	ALIAS
paclitaxel	Drug	Paclitaxel	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Survival

Secondary outcomes (3)

measure
Tumor response rate
measure
Time to disease progression
measure
Quality of life as measured by the Functional Assessment of Cancer -Lung (FACT-L) questionnaire at baseline, every 6 weeks during study treatment, and then every 3 months thereafter

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following types:

  * Squamous cell
  * Adenocarcinoma
  * Large cell anaplastic
  * Bronchoalveolar
  * Non-small cell carcinoma not otherwise specified NOTE: Mixed tumors are categorized by the predominant cell type (tumors with small-cell anaplastic elements are ineligible)
* Evidence of at least 1 of the following:

  * Clinically documented recurrent disease after prior radiation or surgery
  * Stage IV disease (distant metastases)
  * Stage IIIB disease presenting with 1 of the following:

    * Pleural or pericardial effusion by CT scan or chest x-ray
    * Pleural implants documented pathologically or seen on CT scan or x-ray
* Measurable or evaluable disease
* No brain metastases unless clinically stable after surgery and/or radiotherapy

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 1.5 mg/dL
* AST less than 5 times upper limit of normal

Renal

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 40 mL/min

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No hypersensitivity to agents that contain Cremophor EL (polyoxyethylated castor oil)

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for advanced NSCLC

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* Recovered from prior radiotherapy
* No prior radiotherapy to the only site of measurable disease, unless the site had subsequent progression of disease documented by physical exam, radiography, or pathology
* No concurrent radiotherapy (except for brain metastases)

Surgery

* See Disease Characteristics

Other

* No concurrent aminoglycoside antibiotics

References

Publications (5)

RESULTEdelman MJ, Belani CP, Socinski MA, Ansari RH, Obasaju CK, Chen R, Monberg MJ, Treat J; Alpha Oncology Research Network. Outcomes associated with brain metastases in a three-arm phase III trial of gemcitabine-containing regimens versus paclitaxel plus carboplatin for advanced non-small cell lung cancer. J Thorac Oncol. 2010 Jan;5(1):110-6. doi: 10.1097/JTO.0b013e3181c59a3a. PMID 20035187
RESULTObasaju CK, Ansari RH, Socinski MA, Chen R, Monberg MJ, Catalano RB, Marinucci DM, Liles DK, Ribeiro MJ, Comis RL, Treat J; Alpha Oncology Research Network. A Comparison of white and African American outcomes from a three-arm, randomized, phase III multicenter trial of advanced or metastatic non-small cell lung cancer. J Thorac Oncol. 2010 Jul;5(7):993-1000. doi: 10.1097/jto.0b013e3181e29cf3. PMID 20593535
RESULTTreat JA, Gonin R, Socinski MA, Edelman MJ, Catalano RB, Marinucci DM, Ansari R, Gillenwater HH, Rowland KM, Comis RL, Obasaju CK, Belani CP; Alpha Oncology Research Network. A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic non-small-cell lung cancer. Ann Oncol. 2010 Mar;21(3):540-547. doi: 10.1093/annonc/mdp352. Epub 2009 Oct 15. PMID 19833819
RESULTTreat J, Edelman MJ, Belani CP, Socinski MA, Monberg MJ, Chen R, Obasaju CK; Alpha Oncology Research Network. A retrospective analysis of outcomes across histological subgroups in a three-arm phase III trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin for advanced non-small cell lung cancer. Lung Cancer. 2010 Dec;70(3):340-6. doi: 10.1016/j.lungcan.2010.02.011. Epub 2010 Mar 27. PMID 20347506
RESULTTreat J, Belani CP, Edelman MJ, et al.: A randomized phase III trial of gemcitabine (G) in combination with carboplatin (C) or paclitaxel (P) versus paclitaxel plus carboplatin in advanced (Stage IIIB, IV) non-small cell lung cancer (NSCLC): update of the Alpha Oncology trial (A1-99002L). [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7025, 627s, 2005.

Registry

Dates and enrollment

Start: Sep 1, 2001
Primary completion: Sep 1, 2001
Completion: Sep 1, 2001
First posted: Feb 6, 2003
Last update posted: Jul 11, 2013
Enrollment: 0 (actual)
Lead sponsor: Fox Chase Cancer Center OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung

Data updated 22 days agoSource updated Jul 11, 2013source: clinicaltrials

Locations

Locations by country (57)

Country	Sites	Recruiting
United States	57	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.