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Drug/Agent Toxicity by Tissue/OrganPhase 1/2NCT00006012

Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

A Phase 1/2 study testing filgrastim, amifostine trihydrate and cisplatin in people with Drug/Agent Toxicity by Tissue/Organ and Lung Cancer, run by Alliance for Clinical Trials in Oncology at 84 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 work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
filgrastim, amifostine trihydrate and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
84 sitesUnited States
Study dates
Feb 2001to May 2006
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer
  • Limited disease confined to one hemithorax, the ipsilateral supraclavicular fossa, and encompassable within tolerable thoracic radiotherapy field
  • Minimal pleural effusions (i.e., blunting of the costophrenic angle on chest x-ray or a small effusion on CT scan) allowed
  • Measurable disease
  • At least one lesion accurately measured in at least 1 dimension with longest diameter at least 20 mm

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

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 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Pulmonary:

  • FEV_1 at least 40% of predicted AND at least 1 liter

Other:

  • No uncontrolled infection
  • No other severe underlying diseases
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas (carcinoma in situ)
  • No grade 2 or greater peripheral neuropathy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No hypersensitivity to E.coli-derived proteins, filgrastim (G-CSF), or any excipients of G-CSF

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior hemithorax radiotherapy

Surgery

  • Not specified

Other

  • No prior therapy for small cell lung cancer

Trial locations and contacts

84 sites in 1 country.

84 sites in 1 country

United States84 sites

  • McFarland Clinic, P.C.

    Ames, Iowa, 50010

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48100

  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • MeritCare Clinic - Bemidji

    Bemidji, Minnesota, 56601

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Cancer Care Center at Medcenter One Hospital

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, P.C.

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center

    Bismarck, North Dakota, 58501

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Graham Hospital

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas, P.A. - El Dorado

    El Dorado, Kansas, 67042

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Medical Group

    Fargo, North Dakota, 58122

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48532

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • Mason District Hospital

    Havana, Illinois, 62644

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224-9980

  • Joliet Oncology Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Franciscan Skemp Healthcare

    La Crosse, Wisconsin, 54601

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Bryan LGH Medical Center West

    Lincoln, Nebraska, 68502

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • St. Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois - Ottawa

    Ottawa, Illinois, 61350

  • Cancer Center of Kansas, P.A. - Parsons

    Parsons, Kansas, 67357

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

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

    Peoria, Illinois, 61615

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Pratt Cancer Center of Kansas

    Pratt, Kansas, 67124

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan, 48601

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67042

  • CCOP - Mayo Clinic Scottsdale Oncology Program

    Scottsdale, Arizona, 85259

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101-1733

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57104

  • Avera McKennan Hospital and University Health Center

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center

    Sioux Falls, South Dakota, 57105

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Valley Cancer Center

    Spring Valley, Illinois, 61362

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • St. John Macomb Hospital

    Warren, Michigan, 48903

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Associates in Womens Health

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, P.A.

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, P.A. - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

Other trials in United States

About this study

Official title: Phase I-II Study of Topotecan and Paclitaxel Followed by High-Dose Thoracic Radiation Therapy With Concomitant Cisplatin/Etoposide and Amifostine in Limited-Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy before, during, and after radiation therapy in treating patients who have limited-stage small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of thoracic radiotherapy administered with cisplatin, etoposide, and amifostine preceded and followed by topotecan and paclitaxel in patients with limited stage small cell lung cancer (phase I closed to accrual as of 5/27/2004).
  • Determine the two-year survival of this patient population treated with this regimen.
  • Determine the two-year, progression-free local control rate in this patient population treated with this regimen.
  • Assess the tolerability of this treatment regimen in these patients.
  • Determine the antitumor activity of this regimen in these patients.
  • Determine the overall survival and overall time to progression in this patient population treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of thoracic radiotherapy (TRT).

Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses.

After 2 courses of topotecan and paclitaxel, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT.

At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation.

Cohorts of 3-6 patients receive escalating doses of TRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity (phase I closed to accrual as of 5/27/2004).

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 3-73 patients will be accrued for this study (phase I closed to accrual as of 5/27/2004).

Being tested
filgrastim, amifostine trihydrate, cisplatin, etoposide, paclitaxel
Keywords
drug/agent toxicity by tissue/organ, radiation toxicity, limited stage small cell lung cancer
Medical subject headings
Drug-Related Side Effects and Adverse Reactions, Lung Neoplasms, Radiation Injuries

What participants receive

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

Study groups in NCT00006012
Study groupRoleWhat they receive
topotecan + paclitaxel + filgrastim + TRT + radiationExperimentalPatients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses. After 2 courses of treatment, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT. At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
Receives: Biological: filgrastim; Drug: amifostine trihydrate; Drug: cisplatin; Drug: etoposide; Drug: paclitaxel; Drug: topotecan hydrochloride; Radiation: radiation therapy

What is being measured

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

  1. Survival at 2 years

    Measured: at 2 years

Secondary outcomes (3)

  1. Local progression-free survival at 2 years

    Measured: at 2 years

  2. Overall survival

    Measured: Up to 5 years

  3. Time to progression

    Measured: Up to 5 years

Timeline

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

  1. First posted8 Oct 2003 (estimated)
  2. Study startFeb 2001
  3. Primary completionMay 2006
  4. Study completionMay 2006

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006012
Sponsor's protocol ID
NCCTG-N9923
Other IDs
CDR0000068021
Status last verified
Jul 2016
First submitted
5 Jul 2000
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Garces YI, Okuno SH, Schild SE, Mandrekar SJ, Bot BM, Martens JM, Wender DB, Soori GS, Moore DF Jr, Kozelsky TF, Jett JR. Phase I North Central Cancer Treatment Group Trial-N9923 of escalating doses of twice-daily thoracic radiation therapy with amifostine and with alternating chemotherapy in limited stage small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):995-1001. doi: 10.1016/j.ijrobp.2006.10.034.

    PubMed 17336213

  • Garces YI, Okuno SH, Schild SE, et al.: A phase I/II NCCTG trial of escalating doses of twice daily thoracic radiation therapy (TRT) in limited-stage small cell lung cancer (LSCLC). [Abstract] J Clin Oncol 23 (Suppl 16): A-7163, 661s, 2005.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing filgrastim, amifostine trihydrate and cisplatin in people with Drug/Agent Toxicity by Tissue/Organ and Lung Cancer, run by Alliance for Clinical Trials in Oncology at 84 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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Survival at 2 years (time frame: at 2 years). 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 NCT00006012, which also lists 2 linked publications.

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 6 Jul 2016.

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