Study of Velcade and Irinotecan in Advanced Cervical, Vulvar, or Vaginal Cancer

NCT00106262 | Terminated Phase 2

• 1 other identifier: X05122
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducting an evaluation of two chemotherapy drugs, Velcade and Irinotecan, in women with advanced, recurrent, or metastatic cervical cancer, vaginal cancer, or vulvar cancer. Patients with cervical cancer may have received a platinum-containing treatment as systemic therapy without radiation, but is not required.

Conditions

Cervical Cancer

Keywords

advanced cervical cancer; metastatic cervical cancer

Outcome Measures

Primary Outcomes (2)

• overall response rate

• time to progression

Secondary Outcomes (2)

• overall survival

• toxicity of this combination in women with advanced cervical cancer

Interventions

Velcade (bortezomib) DRUG

Irinotecan DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• age \> 18
• Karnofsky performance status \> 60%
• Measurable disease on clinical exam or by RECIST criteria
• One prior platinum-based systemic chemotherapy regimen for advanced disease is allowed but not required. Chemotherapy administered as a radiosensitizer in conjunction with primary radiotherapy is not considered a systemic chemotherapy regimen and is also allowed. Patients eligible for a higher priority study will be excluded.
• Life expectancy \> 6 weeks
• Peripheral neuropathy ≤ Grade 2 by CTC 3.0 criteria
• Women of child-bearing potential must have a negative pregnancy test
• Adequate hematopoietic function defined as: ANC ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL.
• Adequate renal and hepatic function defined as: Bilirubin ≤ 1.5 times upper limit of normal (ULN); SGOT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 2.5 times ULN; Creatinine ≤ 2 times ULN.

You may not qualify if:

• Patient has hypersensitivity to bortezomib, boron or mannitol.
• Female subject is pregnant or breast-feeding.
• Patient has received other investigational drugs with 14 days before enrollment
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Prior treatment with CAMPTOSAR or VELCADE
• More than one prior treatment for metastatic disease.
• Concurrent uncontrolled illness
• Ongoing or active infection
• History or active secondary cancer within the last 5 years, except for superficial basal cell skin cancers
• Psychiatric illness or social situation that would preclude study compliance.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Women & Infants' Hospital

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Bortezomib; Irinotecan

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)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids

Study Officials

• Don S Dizon, MD

  Women & Infants' Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 21, 2005
• First Posted: March 22, 2005
• Study Start: March 1, 2005
• Study Completion: March 1, 2007
• Last Updated: April 18, 2007

Record last verified: 2007-04

Locations

US (1)