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Lung CancerPhase 1NCT00059761

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

A Phase 1 study testing cisplatin, irinotecan hydrochloride and radiation therapy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 49 sites in United States.

Completed

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use 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 tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
cisplatin, irinotecan hydrochloride and radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
49 sitesUnited States
Study dates
Mar 2003to Nov 2013
Phase
Phase 1
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 by one of two methods:
  • Fine needle aspiration biopsy
  • Two positive sputa
  • Must have limited disease as defined by all of the following:
  • Stage I-IIIB
  • Confined to 1 hemithorax
  • No T4 tumor based on malignant pleural or pericardial effusion
  • Patients with pleural effusion too small to tap under CT guidance and not evident on chest x-ray are allowed
  • No N3 disease based on contralateral hilar or contralateral supraclavicular involvement
  • Measurable or evaluable disease
  • Tumor must be able to be encompassed by specified radiotherapy fields without unacceptable risk of serious pulmonary compromise
  • No complete tumor resection
  • No pericardial effusion (regardless of cytology)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 120,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • No known Gilbert's disease

Renal

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No symptomatic heart disease

Pulmonary

  • Forced expiratory volume (FEV)_1 at least 1.0 L/sec
  • No uncontrolled bronchospasms
  • No uncompensated chronic obstructive pulmonary disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No pre-existing peripheral neuropathy grade 2 or greater
  • No other malignancy within the past 2 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the bladder or cervix
  • No other concurrent serious medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy
  • No concurrent intensity-modulated radiotherapy

Surgery

  • See Disease Characteristics

Other

  • At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks
  • Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out period
  • At least 14 days since prior Hypericum perforatum (St. John's wort)
  • No concurrent EIACDs
  • No concurrent amifostine during chemoradiotherapy
  • Concurrent gabapentin or other non-EIACDs allowed

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Sarah Cannon Cancer Center at Parkridge Medical Center

    Chattanooga, Tennessee, 37404

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Wendt Regional Cancer Center at Finley Hospital

    Dubuque, Iowa, 52001

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • Greenville Hospital System Cancer Center

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Saint Rose Hospital

    Hayward, California, 94545

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Valley Memorial Hospital

    Livermore, California, 94550

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Tucker Center for Cancer Care at Orange Regional Medical Center

    Middletown, New York, 10940

  • Fox Chase Virtua Health Cancer Program - Marlton

    Mount Holly, New Jersey, 08060

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19718

  • Highland General Hospital at St. George's University School of Medicine

    Oakland, California, 94602

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Summit Medical Center

    Oakland, California, 94609

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • Mercy Cancer Institute at Mercy Hospital

    Pittsburgh, Pennsylvania, 15219

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84603

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • J.C. Robinson, M.D. Regional Cancer Center

    San Pablo, California, 94806

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Wilson Medical Center

    Wilson, North Carolina, 27893

Other trials in United States

About this study

Official title: Phase I Study of Irinotecan and Cisplatin in Combination With Twice Daily Thoracic Radiotherapy (45 Gy) or Once Daily Thoracic Radiotherapy (70 Gy) for Patients With Limited Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use 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 tumor cells.

PURPOSE: Phase I trial to study the effect on the body when combining irinotecan and cisplatin with radiation therapy in treating patients who have limited-stage small cell lung cancer that could not be completely removed during surgery.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of irinotecan administered with cisplatin and thoracic radiotherapy (given at two different schedules) in patients with limited stage small cell lung cancer.
  • Determine the qualitative and quantitative toxicity and non-dose-limiting toxicity of these regimens in these patients.
  • Determine the reversibility of all toxic effects associated with these regimens in these patients.

OUTLINE: This is a non-randomized, dose-escalation study of irinotecan. Patients are assigned to 1 of 2 radiotherapy (RT) treatment groups.

  • Radiotherapy:
  • Group I: Patients undergo thoracic RT twice daily, 5 days a week, for 3 weeks.
  • Group II: Patients undergo thoracic RT once daily, 5 days a week, for 7 weeks.
  • Concurrent chemotherapy: Patients receive irinotecan IV over 60-90 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 1 course for group I and 2 courses for group II.
  • Post RT chemotherapy: Patients receive irinotecan and cisplatin as above for 3 courses for group I and 2 courses, beginning after RT is complete, for group II.

Sequential cohorts of 6 patients per group receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

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

PROJECTED ACCRUAL: A total of 12-36 patients (6-18 per group) will be accrued for this study within 18 months.

Conditions
Lung Cancer
Being tested
cisplatin, irinotecan hydrochloride, radiation therapy
Keywords
limited stage small cell lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

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

Study groups in NCT00059761
Study groupRoleWhat they receive
Sequence A: Level 1ExperimentalIrinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
Receives: Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy
Sequence B: Level 1ExperimentalIrinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
Receives: Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy
Sequence A: Level 2ExperimentalIrinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
Receives: Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy
Sequence B: Level 2ExperimentalIrinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
Receives: Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy
Sequence A: Level 3ExperimentalIrinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
Receives: Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy
Sequence B: Level 3ExperimentalIrinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
Receives: Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy

What is being measured

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

  1. Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity

    Measured: From the start of treatment until 90 days

Secondary outcomes (1)

  1. Rate of non-dose limiting toxicity

    Measured: From start of treatment to the end of follow-up

Timeline

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

  1. First posted7 May 2003 (estimated)
  2. Study startMar 2003
  3. Primary completionMar 2009
  4. Study completionNov 2013

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00059761
Sponsor's protocol ID
RTOG-0241
Other IDs
CDR0000269348
Status last verified
Nov 2015
First submitted
6 May 2003
Last updated
17 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Langer CJ, Swann S, Werner-Wasik M, et al.: Phase I study of irinotecan (Ir) and cisplatin (DDP) in combination with thoracic radiotherapy (RT), either twice daily (45 Gy) or once daily (70 Gy), in patients with limited (Ltd) small cell lung carcinoma (SCLC): early analysis of RTOG 0241. [Abstract] J Clin Oncol 24 (Suppl 18): A-7058, 378s, 2006.

  • Langer C, Swann S, Werner-Wasik M, et al.: Phase I study of combination irinotecan and cisplatin and either twice daily thoracic radiation (45Gy) or once daily thoracic radiotherapy (70Gy) in patients with limited small cell lung carcinoma (SCLC): early toxicity analysis of RTOG 0241. [Abstract] Lung Cancer 49 (Suppl 2): A-P-777, S323, 2005.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cisplatin, irinotecan hydrochloride and radiation therapy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 49 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 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 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 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.

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?

Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity (time frame: From the start of treatment until 90 days). 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 NCT00059761, 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 17 Nov 2015.

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