Clinical trial · Interventional

Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer

NCT00077311CI-TRIAL-00022791completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy. PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Conditions

Conditions (4)

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

Condition (as posted)	Mapped entity	Match	Confidence
Anemia	—	UNRESOLVED	—
Drug/Agent Toxicity by Tissue/Organ	—	UNRESOLVED	—
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Neutropenia	—	UNRESOLVED	—

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
BNP7787	Drug	—	UNRESOLVED
cisplatin	Drug	Cisplatin	ALIAS
darbepoetin alfa	Biological	—	UNRESOLVED
docetaxel	Drug	Docetaxel	ALIAS
pegfilgrastim	Biological	Pegfilgrastim	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Chemotherapy without BNP7787
description
Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
interventionNames
1. Biological: darbepoetin alfa
2. Biological: pegfilgrastim
3. Drug: cisplatin
4. Drug: docetaxel
type
EXPERIMENTAL
label
Chemotherapy + BNP7787
description
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
interventionNames
1. Biological: darbepoetin alfa
2. Biological: pegfilgrastim
3. Drug: cisplatin
4. Drug: docetaxel
5. Drug: BNP7787

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed\* non-small cell lung cancer of 1 of the following subtypes:

  * Squamous carcinoma
  * Basaloid carcinoma
  * Adenocarcinoma
  * Bronchoalveolar carcinoma
  * Adenosquamous carcinoma
  * Large cell carcinoma
  * Large cell neuroendocrine carcinoma
  * Giant cell carcinoma
  * Sarcomatoid carcinoma
  * Non-small cell carcinoma not otherwise specified NOTE: \*Histologic or cytologic confirmation of recurrence is required for patients who have undergone prior complete resection
* Stage IIIB disease due to malignant pleural effusion OR stage IV disease
* Measurable disease

  * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  * The following are considered nonmeasurable disease:

    * Bone lesions
    * Brain metastases or leptomeningeal disease
    * Ascites
    * Pleural/pericardial effusion
    * Abdominal masses not confirmed and followed by imaging techniques
    * Cystic lesions
    * Tumor lesions situated in a previously irradiated area
* Brain metastases are allowed provided patient is neurologically stable and off steroids

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin ≤ 1.5 mg/dL
* AST ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN

Renal

* Creatinine ≤ ULN

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No grade 2 or greater neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No other concurrent growth factors

Chemotherapy

* No prior chemotherapy
* No other concurrent chemotherapy

Endocrine therapy

* See Disease Characteristics
* No concurrent hormonal therapy except steroids administered for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy

* See Disease Characteristics
* Prior radiotherapy allowed for brain metastases only
* No concurrent palliative radiotherapy

Surgery

* See Disease Characteristics

References

Publications (1)

RESULTMiller AA, Wang XF, Gu L, Hoffman P, Khatri J, Dunphy F, Edelman MJ, Bolger M, Vokes EE, Green MR; Cancer and Leukemia Group B (CALGB). Phase II randomized study of dose-dense docetaxel and cisplatin every 2 weeks with pegfilgrastim and darbepoetin alfa with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (CALGB 30303). J Thorac Oncol. 2008 Oct;3(10):1159-65. doi: 10.1097/JTO.0b013e318186fb0d. PMID 18827613

Registry

Dates and enrollment

Start: Aug 1, 2004
Primary completion: Jul 1, 2006
Completion: Apr 1, 2009
First posted: Feb 12, 2004
Last update posted: Jun 30, 2016
Enrollment: 160 (actual)
Lead sponsor: Alliance for Clinical Trials in Oncology OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: drug/agent toxicity by tissue/organ, anemia, neutropenia, stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, adenosquamous cell lung cancer

Data updated 22 days agoSource updated Jun 30, 2016source: clinicaltrials

Locations

Locations by country (64)

Country	Sites	Recruiting
United States	64	0

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