Study of Nimotuzumab, Radiation Therapy and Cisplatin Versus Radiation Therapy and Cisplatin for Treatment of Stage IB e IVA UCC(CORUS)

NCT01301612 | Withdrawn Phase 2

• 1 other identifier: EF 110
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

The primary study objective will be to assess the efficacy of the combination of radiation therapy with nimotuzumab and cisplatin, as compared to the combination of radiation therapy plus cisplatin in the treatment of Uterine Cervical Carcinoma (UCC). The secondary study objectives will be safety and tolerability evaluations, to determine treatment feasibility and the interim efficacy evaluation according to other parameters routinely used in oncology.

Conditions

Carcinoma; Adenocarcinoma; Uterine Cervix Adenosquamous Carcinoma

Keywords

carcinoma or adenocarcinoma or uterine cervix adenosquamous carcinoma

Outcome Measures

Primary Outcomes (1)

• Local control of disease

  Local control of disease will be measured by magnetic resonance imaging (MRI), clinical gynecological examinations, as well as by biopsy (if indicated), 12 weeks after treatment end.

  1 year

Secondary Outcomes (1)

• Complete clinical response rate

  3 years

Study Arms (2)

Radiation therapy and Cisplatin

ACTIVE COMPARATOR

Cisplatin, 40 mg/m2, IV - Weekly doses for 6 weeks Pelvic radiation therapy, 45 Gy External, Fractions of 1.8 Gy per day, 5 days a week Dose boosts,15 Gy ± 5%, External, Daily fractions of 1.8 Gy or 2 Gy per day, 5 days a week Brachytherapy (if indicaed), 40 Gy at spot A(low dose rate), Intracavitary 1 or 2 separate fractions for 1 to 3 weeks. 28 Gy at spot A, (high dose rate) Intracavitary,4 fractions of 7.0 Gy once or twice a week.

Drug: Cisplatin; Radiation: Radiation Therapy

Nimotuzumab and

EXPERIMENTAL

Cisplatin, 40 mg/m2, IV, Weekly doses for 6 weeks. Nimotuzumab, 200 mg, Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes, Weekly doses for 14 weeks. Pelvic radiation therapy, 45 Gy, External, Fractions of 1.8 Gy per day, 5 days a week. Dose boosts, 15 Gy ± 5%, External,Daily fractions of 1.8 Gy or 2 Gy per day, 5 days a week Brachytherapy (In case there is indication, should it be performed, not to be longer than the expected 70 days for the entire radiation therapy), 40 Gy at spot A (low dose rate) Intracavitary 1 or 2 separate fractions for 1 to 3 weeks 28 Gy at spot A (high dose rate), Intracavitary, 4 fractions of 7.0 Gy once or twice a week.

Drug: Nimotuzumab; Drug: Cisplatin; Radiation: Brachytherapy

Interventions

Nimotuzumab DRUG

Nimotuzumab, 200 mg, IV, Weekly doses for 14 weeks

Nimotuzumab and

Cisplatin DRUG

Cisplatin, 40 mg/m2, IV, Weekly doses for 6 weeks

Nimotuzumab and

Brachytherapy RADIATION

Brachytherapy: 40 Gy at spot A(low dose rate, Intracavitary, 1 or 2 separate fractions for 1 to 3 weeks. Brachytherapy: 28 Gy at spot A (high dose rate), Intracavitary 4 fractions of 7.0 Gy once or twice a week.

Nimotuzumab and

Radiation Therapy RADIATION

Pelvic radiation therapy: 45 Gy, External, Fractions of 1.8 Gy per day, 5 days a week. Dose boosts: 15 Gy ± 5%, External, Daily fractions of 1.8 Gy or 2 Gy per day, 5 days a week. Brachytherapy 40 Gy at spot A(low dose rate.) Intracavitary 1 or 2 separate fractions for 1 to 3 weeks. 28 Gy at spot A (high dose rate, Intracavitary, 4 fractions of 7.0 Gy once or twice a week

Radiation therapy and Cisplatin

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years;
• Diagnosis of histologically confirmed stages IB2 (\> 4 cm) to IVA prickle-cell carcinoma or adenocarcinoma or uterine cervix adenosquamous carcinoma, according to FIGO system,7 (see Appendix A for guidance about staging);
• Measurable disease according to RECIST 1.139 or at least disease evaluable through imaging methods and/or gynecological examination (magnetic resonance imaging (MRI) scans within six weeks prior to randomization will be accepted, computed tomography will accepted in case MRI is contraindicated);
• Indication of definitive treatment with chemotherapy and radiation therapy, at the investigator's discretion;
• Performance status \< 2, according to the Eastern Cooperative Oncology Group criteria 40 (ECOG; see Appendix C);
• Adequate body functions, indicated by:Serum creatinine \< 1.2 mg/100 mL; Creatinine clearance \> 60 mL/min (estimate); Bilirubin up to 1.5-fold the upper limit of normal (ULN) and transaminases, alkaline phosphatase and gamma-glutamyltransferase up to 2.5-fold the ULN; Leucocytes \> 3,000/μL; Neutrophils \> 1,500/μL; Hemoglobin \> 10 g/dL; Platelets \> 80,000/μL;
• Signed informed consent form.

You may not qualify if:

• Para-aortic lymph nodes involvement through radiological and/or surgical staging, at investigator's discretion;
• Current severe comorbidity that, in the investigator's opinion, would put the patient at a significantly higher risk or will jeopardize protocol compliance;
• Current bowel inflammatory disease;
• Current major neurological or psychiatric disease, including clinically significant dementia and seizures, at the investigator's discretion;
• Known hypersensitivity or allergic reactions to study treatment;
• Current uncontrolled hypercalcemia (\> 11,5 mg/dL, that is, grade \> 1 according to Common Terminology Criteria for Adverse Events \[CTCAE\] v4.02, of US National Cancer Institute)41;
• Know HIV positive status (enrollment of patients with hepatitis B or C is at the investigator's discretion);
• Pregnancy or lactation;
• Female patients, as well as their partners, who wish to become pregnant or are unwilling to use an appropriate contraceptive method throughout the study period.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (7)

Centro de Pesquisa Clínica da Liga Norte Riograndense contra o Câncer

Natal, Rio Grande do Norte, 59075740, Brazil

Location

Hospital de Caridade de Ijui - ONCOSITE Centro de Pesquisa Clínica em Oncologia

Ijuí, Rio Grande do Sul, 98700000, Brazil

Location

Hospital Santa Rita - Núcleo de Novos Tratamentos em Câncer

Porto Alegre, Rio Grande do Sul, 90020-160, Brazil

Location

Caism - Unicamp

Campinas, São Paulo, 13083970, Brazil

Location

Centro de Pesquisas Clínicas da Fundação Amaral Carvalho

Jaú, São Paulo, 17210000, Brazil

Location

ICESP

São Paulo, São Paulo, 01246000, Brazil

Location

Hospital Santa Marcelina

São Paulo, São Paulo, 08270070, Brazil

Location

MeSH Terms

Conditions

Carcinoma; Adenocarcinoma

Interventions

nimotuzumab; Cisplatin; Brachytherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• Sergio Lago

  Núcleo de Novos Tratamentos em Câncer - NNTC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2011
• First Posted: February 23, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2017
• Last Updated: July 14, 2014

Record last verified: 2012-01

Locations

BR (7)