Erlotinib, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB-Stage IVA Cervical Cancer

NCT00428194 | Withdrawn Phase 1 DMC

• 2 other identifiers: 2006LS019UMN-0604M84827
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib and cisplatin may make tumor cells more sensitive to radiation therapy. Giving erlotinib together with cisplatin and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.

Conditions

Cervical Cancer

Keywords

stage IIA cervical cancer; stage IB cervical cancer; stage IIB cervical cancer; stage III cervical cancer; stage IVA cervical cancer; cervical squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of erlotinib hydrochloride

  Day 14

Secondary Outcomes (1)

• Toxicity

  4-6 Weeks Post Last Study Dose

Study Arms (3)

Cohort 1

EXPERIMENTAL

Erlotinib 100 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m\^2 intravenous every 7 days during RT) and continuing daily through radiation

Drug: cisplatin; Drug: erlotinib hydrochloride; Procedure: radiation therapy

Cohort 2

EXPERIMENTAL

Erlotinib 125 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m\^2 intravenous every 7 days during RT) and continuing daily through radiation

Drug: cisplatin; Drug: erlotinib hydrochloride; Procedure: radiation therapy

Cohort 3

ACTIVE COMPARATOR

Erlotinib 150 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m\^2 intravenous every 7 days during RT) and continuing daily through radiation

Drug: cisplatin; Drug: erlotinib hydrochloride; Procedure: radiation therapy

Interventions

cisplatin DRUG

40 mg/m\^2 every 7 days during radiation

Also known as: cisplatinum, CDDP

Cohort 1; Cohort 2; Cohort 3

erlotinib hydrochloride DRUG

Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m\^2 by mouth once a day beginning day 1.

Also known as: Tarceva(R)

Cohort 1; Cohort 2; Cohort 3

radiation therapy PROCEDURE

standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)

Also known as: irradiation

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

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

You may qualify if:

• Diagnosis of squamous cell carcinoma of the cervix
• Stage IB-IVA disease
• Scheduled to undergo standard radiotherapy and receive weekly cisplatin
• ECOG performance status 0-2
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 1 week after completion of study treatment
• Must be able to take oral medication

You may not qualify if:

• Malabsorption syndrome
• Serious underlying medical condition that would impair the ability of patient to receive treatment
• Known hypersensitivity to erlotinib hydrochloride
• Psychological, familial, sociological, or geographical conditions that would preclude study compliance
• Less than 21 days since prior nonapproved or investigational drugs
• Prior chemotherapy
• Prior radiotherapy
• Prior anti-epidermal growth factor receptor treatment
• Prior gastrointestinal surgery that limits absorption (i.e., requiring total parenteral nutrition)
• Concurrent use of any of the following agents and therapies:
• Other antineoplastic or antitumor agents
• Other chemotherapy
• Other investigational agents
• Radiotherapy
• Immunotherapy

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Erlotinib Hydrochloride; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics; Physical Phenomena

Study Officials

• Levi S. Downs, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: January 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)