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AnemiaPhase 2NCT00077311

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

A Phase 2 study testing darbepoetin alfa, pegfilgrastim and cisplatin in people with Anemia and Drug/Agent Toxicity by Tissue/Organ, run by Alliance for Clinical Trials in Oncology at 64 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
darbepoetin alfa, pegfilgrastim and cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
64 sitesUnited States
Study dates
Aug 2004to Apr 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

United States64 sites

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Veterans Affairs Medical Center - Baltimore

    Baltimore, Maryland, 21201

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Graham Hospital

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Veterans Affairs Medical Center - Chicago Westside Hospital

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Veterans Affairs Medical Center - Dallas

    Dallas, Texas, 75216

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • Zale Lipshy University Hospital

    Dallas, Texas, 75235

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Union Hospital Cancer Center at Union Hospital

    Elkton MD, Maryland, 21921

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Mason District Hospital

    Havana, Illinois, 62644

  • New Hampshire Oncology-Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • St. Mary's Regional Cancer Center at St. Mary's Medical Center

    Huntington, West Virginia, 25702

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28501

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Elliot Regional Cancer Center

    Manchester, New Hampshire, 03103

  • El Camino Hospital

    Mountain View, California, 94040

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Cancer Care Associates - Mercy Campus

    Oklahoma City, Oklahoma, 73120

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois - Ottawa

    Ottawa, Illinois, 61350

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology/Hematology Associates of Central Illinois, P.C.

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Arch Medical Services, Incorporated at Center for Cancer Care Research

    St Louis, Missouri, 63141

  • CCOP - Hematology-Oncology Associates of Central New York

    Syracuse, New York, 13057

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Community General Hospital of Greater Syracuse

    Syracuse, New York, 13215

  • Faxton Regional Cancer Center

    Utica, New York, 13502

  • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

    Voorhees Township, New Jersey, 08043

  • St. Francis Hospital

    Wilmington, Delaware, 19805

  • Zimmer Cancer Center at New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without dimesna.
  • Compare the feasibility of these regimens, in terms of febrile neutropenia and treatment delays, in these patients.
  • Compare the objective response rate in patients treated with these regimens.

Secondary

  • Compare the survival and failure-free survival of patients treated with these regimens.
  • Compare the toxicity profile of these regimens in these patients.
  • Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I*: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2.
  • Arm II*: Patients receive docetaxel, cisplatin, and pegfilgrastim as in arm I and dimesna IV over 30 minutes on day 1.

NOTE: *In both arms, darbepoetin alfa is administered SC on day 1 of each course for hemoglobin ≤ 11 g/dL.

In both arms, treatment repeats every 2 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Being tested
darbepoetin alfa, pegfilgrastim, cisplatin, docetaxel, BNP7787
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
Medical subject headings
Anemia, Drug-Related Side Effects and Adverse Reactions, Lung Neoplasms, Neutropenia, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • darbepoetin alfaBiological

    200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL

  • pegfilgrastimBiological

    6 mg sub Q day 2 of each cycle

  • cisplatinDrug

    75 mg/sq m IV over 1 hr Day 1 of each cycle

  • docetaxelDrug

    75 mg/sq m IV over 1 hr Day 1 of each cycle

  • BNP7787Drug

    40 g IV over 30 min Day 1 of each cycle

Study groups in NCT00077311
Study groupRoleWhat they receive
Chemotherapy without BNP7787ExperimentalChemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
Receives: Biological: darbepoetin alfa; Biological: pegfilgrastim; Drug: cisplatin; Drug: docetaxel
Chemotherapy + BNP7787ExperimentalChemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
Receives: Biological: darbepoetin alfa; Biological: pegfilgrastim; Drug: cisplatin; Drug: docetaxel; Drug: BNP7787

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity

    Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity

    Measured: 12 weeks

Secondary outcomes (2)

  1. Response

    Measured: during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs

  2. Survival

    Measured: q 6 mon for 2 yrs after registration, then annually

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2004 (estimated)
  2. Study startAug 2004
  3. Primary completionJul 2006
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077311
Sponsor's protocol ID
CALGB-30303
Other IDs
U10CA031946, CALGB-30303, CDR0000350089
Status last verified
Jun 2016
First submitted
10 Feb 2004
Last updated
30 Jun 2016
Results posted
No
Data monitoring committee
No

Publications

  • Miller 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.

    PubMed 18827613

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing darbepoetin alfa, pegfilgrastim and cisplatin in people with Anemia and Drug/Agent Toxicity by Tissue/Organ, run by Alliance for Clinical Trials in Oncology at 64 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00077311, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.

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