Nedaplatin/Docetaxel Versus Cisplatin/Docetaxel in Treatment of Advanced/Relapsed Squamous Cell Lung Cancer

NCT02643407 | Unknown Phase 3 DMC

• 1 other identifier: CTONG1501
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of docetaxel plus nedaplatin with docetaxel plus cisplatin in managment of advanced/relapsed squamous cell lung cancer.

Conditions

Non-Small Cell Lung Cancer

Keywords

squamous cell carcinoma; nedaplatin; cisplatin; docetaxel

Outcome Measures

Primary Outcomes (1)

• PFS

  30 months

Study Arms (2)

Docetaxel plus Nedaplatin

EXPERIMENTAL

docetaxel 60mg/m2 and nedaplatin 80mg/m2, d1 every 3 weeks

Drug: Docetaxel; Drug: Nedaplatin

Docetaxel plus Cisplatin

ACTIVE COMPARATOR

docetaxel 60mg/m2 and cisplatin 75mg/m2, d1 every 3 weeks

Drug: Docetaxel; Drug: Cisplatin

Interventions

Docetaxel DRUG

60mg/m2

Docetaxel plus Cisplatin; Docetaxel plus Nedaplatin

Nedaplatin DRUG

80mg/m2

Docetaxel plus Nedaplatin

Cisplatin DRUG

75mg/m2

Docetaxel plus Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were required to be between 18 to 75 years, with histologically or cytologically proven squamous cell carcinoma of the lung, stage ⅢB (unfit for definitive radiotherapy), stage Ⅳ or relapsing;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of zero or one;
• life expectancy \> 3 months;
• No previous history of malignancy (except adequately treated carcinoma-in-situ of the cervix or basal cell carcinoma of the skin or superficial bladder cancer \[Ta, Tis \& T1\]); previously untreated with chemotherapy (eg. gemcitabine, platinum, paclitaxel); no previously systemic therapy on locally advanced and metastatic disease; patients were eligible for participation in the study if they had recurrence or metastasis and became locally advanced or metastatic lung cancer after 12 months treatment with gemcitabine, platinum or paclitaxel regimen in adjuvant or neoadjuvant chemotherapy;
• Adequate organ function was required, as evidenced by absolute neutrophil count ≥ 1.5 x 109 /L, platelet count ≥ 100 x109/L, hemoglobin ≥ 90 g/L (9 g/dL);
• hepatic enzyme levels ≤ 2.5 x the upper limit of the normal range (ULN), alkaline phosphatase levels ≤ 5.0 x the ULN, total bilirubin levels ≤ 1.5 x the ULN, and serum creatinine levels ≤1.5 mg/dL (or creatinine clearance ≥50 mL/min);
• Previous radiotherapy was allowed if it involved \<25% of bone marrow and was completed 4 weeks before study entry; Patients must be recovered from acute toxicity before the clinical trials;
• Pregnancy test: negative (female only); Women with fertility need pregnancy test (serum or urine) in 7 days before entering the group and the results were negative. Male or female patients with reproduction potential had to use an approved contraceptive method during and for 8 weeks after the end of study treatment.
• Patients are judged by researcher to be the compliance of research requirements and follow-up.
• All the patients provided their written informed consent before enrollment.
• The standard first-line platinum-based regimens according to the clinical practice, and the efficacy was evaluated every two cycles.

You may not qualify if:

• EGFR positive or ALK positive (patients, the status of EGFR and ALK were unknown due to the detection, were included);
• Participation in any clinical research in 4 weeks before the first dosage, except non interventional epidemiological investigation;
• Patients with the complications in high risk;
• Primary brain tumors or central nervous system (CNS) metastatic carcinoma. The patients who are suspected the CNS metastatic carcinoma should be scanned in 28 days before entering the group. Other malignant disease five years ago (except cone-biopsied carcinoma-in-situ of the cervix or adequately treated basal or squamous cell carcinoma of the skin)
• Third-space fluid collection that has the clinical significance, such as ascites or pleural effusion, cannot control through the drainage or other method;
• Serious mental retardation or cognitive impairment, psychotic illness, poor compliance, cannot meet and narrate therapy responders;
• No eliminated acute or chronic infection, or other serious concomitant diseases;
• Serious or uncontrolled concomitant disorders (active infection, ischemic heart diseases, arrhythmia, liver dysfunction, or peripheral nerve disorder);
• Patients with bleeding tendency or organ transplant;
• Alcohol or drug dependent patients; patients with the chronic administration of adrenal cortical hormone or immunosuppressive; patients with AIDS or other infectious diseases;
• Active hepatitis, liver metastasis is over 3/4 of the whole liver;
• A history of drug allergy;
• The female patients in the reproductive years are unwilling contraception;
• Accept other anti-tumor therapy at the same time;
• The researchers believe that the patients are not able to complete the entire clinical trial.

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

Study Sites (1)

Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell

Interventions

Docetaxel; nedaplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: December 31, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

CN (1)