## Protocol Section
### Identification Module
**NCT ID:** NCT00006079

**Brief Title:** Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

**Official Title:** A Randomized Double-Blind Study of Alpha-Difluromethylornithine (DFMO) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3

#### Organization Study ID Info
**ID:** ID92-026
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**ID:** P30CA016672
**Link:** https://reporter.nih.gov/quickSearch/P30CA016672
**Type:** NIH
**Domain:** UT MD Anderson Cancer Center
**ID:** MDA-ID-92026
**Type:** OTHER
**ID:** NCI-P00-0149
**Domain:** NCI PDQ
**ID:** CDR0000067921
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2004-04-27

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-10-25

**Type:** ACTUAL

**Last Update Submit Date:** 2018-10-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2004-04-27

**Type:** ACTUAL

#### Start Date
**Date:** 1998-06-19

**Type:** ACTUAL

**Status Verified Date:** 2018-10

#### Study First Post Date
**Date:** 2004-05-26
**Type:** ESTIMATED
**Study First Submit Date:** 2000-08-03
**Study First Submit QC Date:** 2004-05-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of eflornithine may be an effective way to prevent the recurrence of or further development of cervical cancer.

PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing cervical cancer in patients who have cervical intraepithelial neoplasia.

**Detailed Description:** OBJECTIVES: I. Compare the efficacy of eflornithine versus placebo in causing regression in patients with cervical intraepithelial neoplasia. II. Compare the qualitative and quantitative toxicities of these treatment regimens in these patients. III. Establish the biochemical tissue markers of DNA content, PCNA, the ras oncogene, EGFR, and keratin and involucrin as intermediate biomarker end points for squamous carcinogenesis in these patients.

OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to one of three treatment arms. Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Arm III: Patients receive oral placebo daily. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, and then at 6, 12, 18, and 24 months.

PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.

### Conditions Module

**Conditions:**

- Cervical Cancer

- Precancerous Condition

**Keywords:**

- cervical cancer

- cervical intraepithelial neoplasia grade 2

- cervical intraepithelial neoplasia grade 3

- Eflornithine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 150

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.

**Intervention Names:**

- Drug: Eflornithine

**Label:** Arm I

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.

**Intervention Names:**

- Drug: Eflornithine

**Label:** Arm II

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Arm III: Patients receive oral placebo daily. Treatment continues for 28 days.

**Intervention Names:**

- Other: Placebo

**Label:** Arm III

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm I

- Arm II

**Description:** Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.

**Name:** Eflornithine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Arm III

**Description:** Patients receive oral placebo daily for 28 days.

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Efficacy in causing regression in patients with cervical intraepithelial neoplasia measured by absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, and then at 6, 12, 18, and 24 months.

**Measure:** Efficacy Comparison of Eflornithine versus Placebo

**Time Frame:** 28 Days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1) Women with newly diagnosed or recurrent CIN grade 2-3, involving an area 3times larger than the biopsy site. Patients must be \> 18 years old, with a performance status less than or equal to 2 (Zubrod Scale) and a predicted life expectancy of greater than or equal to 12 months. Patients must have a medically safe form of contraception for the duration of the study. All patients must complete the of pretreatment evaluation, consent to colposcopy and cervical biopsy for histologic evaluation

Exclusion Criteria:

1) Patients may not have had a prior malignancy.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Houston

**Country:** United States

**Facility:** University of Texas - MD Anderson Cancer Center

**State:** Texas

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** M.D. Anderson Cancer Center

**Name:** Michele Follen, MD, PhD

**Role:** STUDY_CHAIR

### References Module

#### See Also Links

**Label:** UT MD Anderson Cancer Center Website

**URL:** http://www.mdanderson.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000002577

- Term: Uterine Cervical Diseases

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5830

- Name: Uterine Cervical Neoplasms

- Relevance: HIGH

- As Found: Cervical Cancer

- ID: M14111

- Name: Precancerous Conditions

- Relevance: HIGH

- As Found: Precancerous Condition

- ID: M5826

- Name: Uterine Cervical Dysplasia

- Relevance: HIGH

- As Found: Cervical Intraepithelial Neoplasia

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5825

- Name: Uterine Cervical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T1074

- Name: Cervical Intraepithelial Neoplasia

- Relevance: HIGH

- As Found: Cervical Intraepithelial Neoplasia

### Condition Browse Module - Meshes

- ID: D000002583

- Term: Uterine Cervical Neoplasms

- ID: D000009369

- Term: Neoplasms

- ID: D000002578

- Term: Uterine Cervical Dysplasia

- ID: D000011230

- Term: Precancerous Conditions

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000014344

- Term: Trypanocidal Agents

- ID: D000000981

- Term: Antiprotozoal Agents

- ID: D000000977

- Term: Antiparasitic Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000065108

- Term: Ornithine Decarboxylase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M3859

- Name: Eflornithine

- Relevance: HIGH

- As Found: SPI

- ID: M4298

- Name: Antiprotozoal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4294

- Name: Antiparasitic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T13

- Name: Ornithine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000518

- Term: Eflornithine

### Misc Info Module

- Version Holder: 2024-05-24
