Study of Velcade and Irinotecan in Advanced Cervical, Vulvar, or Vaginal Cancer
This study has been terminated.
(Lack of accrual)
Sponsor:
Women and Infants Hospital of Rhode Island
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by:
Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00106262
First received: March 21, 2005
Last updated: April 17, 2007
Last verified: April 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: Velcade (bortezomib) Drug: Irinotecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of VELCADE TM(PS-341) and Irinotecan in the Treatment of Progressive, Recurrent or Metastatic Cervical, Vulvar, or Vaginal Cancer |
Resource links provided by NLM:
Further study details as provided by Women and Infants Hospital of Rhode Island:
Primary Outcome Measures:
- overall response rate
- time to progression
Secondary Outcome Measures:
- overall survival
- toxicity of this combination in women with advanced cervical cancer
| Estimated Enrollment: | 38 |
| Study Start Date: | March 2005 |
| Study Completion Date: | March 2007 |
This is a phase 2 study. Patients with advanced or metastatic histologically documented squamous cell carcinoma, adenocarcinoma, or adenosquamous cancers originating in the cervix, vagina, or vulva will be eligible. Measurable disease by either clinical exam or radiography is also required. Patients receiving cisplatin-based chemoradiation as definitive treatment for local disease will be eligible. Patients must have no more than one prior platinum-based chemotherapy regimen in the metastatic setting. Patients presenting with distant metastatic disease (beyond the pelvis) will be eligible, as long as they are not eligible for a higher priority study.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106262
Locations
| United States, Rhode Island | |
| Women & Infants' Hospital | |
| Providence, Rhode Island, United States, 02905 | |
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Millennium Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Don S Dizon, MD | Women & Infants' Hospital of Rhode Island |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00106262 History of Changes |
| Other Study ID Numbers: | X05122 |
| Study First Received: | March 21, 2005 |
| Last Updated: | April 17, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Women and Infants Hospital of Rhode Island:
|
advanced cervical cancer metastatic cervical cancer |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Vaginal Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Vaginal Diseases Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Irinotecan |
Bortezomib Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protease Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013