Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin

NCT00055965 | Unknown Phase 3

• 3 other identifiers: CDR0000271903CHNT-GEM-HOSPEU-20245
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if one regimen will require patients to spend more time in the hospital than the other regimen for treatment of chemotherapy-related side effects. PURPOSE: Randomized phase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Rate of hospitalization due to toxicity

Secondary Outcomes (6)

• Need for hospitalization for chemotherapy administration

• Tumor response rate

• Overall survival

• Relief of tumor-related symptoms

• Effect on Karnofsky performance status

Interventions

carboplatin DRUG

cisplatin DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed inoperable non-small cell lung cancer * Stage IIIA, IIIB, or IV * Not eligible for curative radiotherapy or surgery * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 50-100% Life expectancy * At least 12 weeks Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST no greater than 2.5 times ULN * Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present) Renal * Creatinine no greater than ULN OR * Creatinine clearance at least 60 mL/min Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study completion * No active infection * No serious systemic disorder that would preclude study participation * No grade 2 or greater peripheral neuropathy * No significant neurological problems (e.g., seizures or psychiatric disorders) * No other active malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior cytotoxic chemotherapy * No other concurrent chemotherapy during or for 7 days after study therapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior radiotherapy * No concurrent radiotherapy during or for 7 days after study therapy Surgery * See Disease Characteristics Other * At least 12 weeks since prior investigational agents * No other concurrent antitumor therapy * No concurrent experimental medications

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

Christie Hospital NHS Trust

Manchester, England, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Nick Thatcher, PhD, FRCP

  The Christie NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: November 1, 2002
• Primary Completion: August 1, 2006
• Last Updated: September 20, 2013

Record last verified: 2009-01

Locations

GB (1)