Tirapazamine Combined With Chemo and RT in Limited-Stage Small Cell Lung Cancer

NCT00066742 | Completed Phase 2 Results

• 3 other identifiers: NCI-2012-03042U10CA032102S0222
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well giving tirapazamine together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, 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. Tirapazamine may make the tumor cells more sensitive to chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy with tirapazamine may kill more tumor cells.

Conditions

Limited Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.

  Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.

Secondary Outcomes (2)

• Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.

  After completeion of concurrent chemotherapy+radiation (Week 8); then after completion of consolidation chemotherapy (Week15); once off treatment, every 3 months until disease progression for a maximum of 3 years after enrollment.

• Progression-Free Survival

  At end of concurrent chemoradiotherapy (Week 8), then at end of consolidation chemotherapy (Week 15). After off treatment, every 3 months for the first 2 years then every 6 months for up to 3 years after enrollment.

Study Arms (1)

Treatment (tirapazamine, cisplatin, etoposide)

EXPERIMENTAL

CHEMORADIOTHERAPY: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; cisplatin IV over 1 hour on days 1, 8, 29, and 36; and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks. CONSOLIDATION CHEMOTHERAPY: Within 28 days after completion of radiotherapy, patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: tirapazamine; Drug: cisplatin; Drug: etoposide; Radiation: radiation therapy; Other: laboratory biomarker analysis

Interventions

tirapazamine DRUG

Given IV

Also known as: SR 4233, Tirazone, WIN 59075

Treatment (tirapazamine, cisplatin, etoposide)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (tirapazamine, cisplatin, etoposide)

etoposide DRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213

Treatment (tirapazamine, cisplatin, etoposide)

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (tirapazamine, cisplatin, etoposide)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (tirapazamine, cisplatin, etoposide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed diagnosis of limited small cell lung cancer; diagnosis on the basis of sputum cytology is acceptable if confirmation by an independent pathologic review at the institution is documented
• Patients must have measurable OR non-measurable disease documented by CT, MRI or X-ray; any scan abnormalities, which may otherwise represent metastatic disease, should be confirmed benign by appropriate tests and documented on the baseline tumor assessment form (form #848); if an abnormality is present at baseline, it is assumed to be disease involvement unless proven otherwise; disease must be assessed within 28 days prior to registration for measurable disease and 42 days prior to registration for non-measurable disease; NOTE: The use of PET scans for tumor imaging is not allowed
• Patients with any brain metastases are ineligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate CNS disease within 42 days prior to registration
• Patients with malignant pericardial effusions OR malignant pleural effusions are ineligible; these are defined as either cytologically positive effusions OR exudative effusions not attributable to other etiologies; patients with effusions too small to tap are eligible
• Patients must have a measured or calculated creatinine clearance \>= 50 cc/min obtained within 28 days prior to registration; serum creatinine is only necessary if calculated CrCl is used; if calculated CrCl is used, serum creatinine must be \< 1.5 mg/dl
• ANC \>= 1,500/ul obtained within 28 days prior to registration
• Platelet count \>= 100,000/ul obtained within 28 days prior to registration
• Serum bilirubin =\< 1.5 x the institutional upper limit of normal within 28 days prior to registration
• SGOT or SGPT =\< 2 x the institutional upper limit of normal within 28 days prior to registration
• All patients must have a Zubrod performance status of 0-1
• Patients must not have received previous chemotherapy or biologic therapy for small cell lung cancer; patients must not have received prior thoracic or neck radiation for any reason
• At least two weeks must have elapsed since surgery (thoracic or other major surgeries) and patients must have recovered from all associated toxicities; measurable or non-measurable disease must be present outside the area of surgical resection
• Patients with significant clinical hearing loss must be willing to accept the potential for worsening of symptoms
• Patients must not have \>= grade 1 symptomatic neuropathy-sensory (NCI Common Terminology Criteria for Adverse Events version 3.0)
• Patients must have a pre-registration FEV1 and DLCO obtained within 28 days prior to registration

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Southwest Oncology Group (SWOG) Research Base

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Interventions

Tirapazamine; Cisplatin; Etoposide; Radiotherapy; Radiation

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Therapeutics; Physical Phenomena

Results Point of Contact

• Title: Lung Committee Statistician
• Organization: SWOG Statistical Center

206-652-2267

Study Officials

• Quynh-Thu Le

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: September 1, 2003
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 15, 2014
• Results First Posted: July 19, 2012

Record last verified: 2012-12

Locations

US (1)