Radiation With Chemotherapy and a Study Drug to the Para-Aortic Nodes in Cervical Cancer

NCT00137358 | Withdrawn Phase 1

• 1 other identifier: ETH175-04D
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Investigator has since decided not to pursue this protocol further. No patients were enrolled. This study is to determine the maximum tolerated dose of external beam radiation to the para-aortic lymph nodes using intensity modulated radiation therapy (IMRT). This protocol will test the hypothesis that the use of IMRT and amifostine will decrease GI toxicity and therefore allow the radiation dose to the para-aortic lymph nodes to be safely escalated.

Conditions

Cervical Cancer

Keywords

Cervical; Uterine; Para-aortic; Nodes; IMRT; Cancer

Outcome Measures

Primary Outcomes (1)

• The primary objective is to determine the maximum tolerated dose (MTD) of external beam radiation to the para-aortic lymph nodes using IMRT and amifostine.

Secondary Outcomes (1)

• The secondary endpoints include local-regional control, overall survival and toxicity.

Interventions

Radiation Therapy PROCEDURE

Cisplatin DRUG

Amifostine DRUG

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No prior therapy other than biopsy of the cervix or endoscopic pelvic nodal resection.
• Patients may have endoscopic resection of enlarged pelvic and low common iliac nodes, however, needle biopsy only of enlarged para-aortic nodes will be eligible for entry.
• Patients with squamous cell, adenocarcinoma, and adenosquamous carcinoma are eligible.
• Patients must have no evidence of metastatic disease outside of the pelvis (except to the para-aortic nodes).
• Patients must have Zubrod performance status 0-1 and no medical contraindications to the administration of full dose chemotherapy.
• Patients must have a life expectancy \> 6 months
• Adequate bone marrow function: white blood cell (WBC) 3000/mm3 (absolute neutrophil count \[ANC\] 1500/mm3); adequate renal function: creatinine 1.5 mg/dl (urinary diversion is permitted to improve renal function); patients must have bilirubin 1.5 mg/dl, ALT 2 x normal.
• No prior (within last 3 years) or simultaneous malignancies (other than basal cell or non-invasive tumors)

You may not qualify if:

• Complete resection of the involved para-aortic nodes.
• Patients with evidence of bowel adherent to the GTV by contrast enhanced computed tomography (CT) scan will be ineligible.
• Patients with the following histologies will be ineligible: glassy cell, small cell, carcinoid, adenoid cystic, and clear cell.
• Prior (within last 3 years) malignancies other than basal cell carcinoma or non-invasive malignancies.
• Prior chemotherapy.
• Prior pelvic or abdominal radiation (other than transvaginal irradiation to control bleeding).
• Prior tumor-directed surgery other than lymph node sampling/staging
• Life expectancy \< 6 months
• Patients who are pregnant will be ineligible.
• Patients with insulin dependent diabetes will be ineligible.
• Patients who are obese, such that reliable immobilization is not achieved.
• Patients with pain or discomfort that would preclude lying still for extended periods of time.
• Patients with tumors that are bleeding and require more immediate treatment.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• MedImmune LLC: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (18)

• Grigsby PW, Heydon K, Mutch DG, Kim RY, Eifel P. Long-term follow-up of RTOG 92-10: cervical cancer with positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):982-7. doi: 10.1016/s0360-3016(01)01723-0.

  PMID: 11704321 BACKGROUND

• Berman ML, Keys H, Creasman W, DiSaia P, Bundy B, Blessing J. Survival and patterns of recurrence in cervical cancer metastatic to periaortic lymph nodes (a Gynecologic Oncology Group study). Gynecol Oncol. 1984 Sep;19(1):8-16. doi: 10.1016/0090-8258(84)90151-3.

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• Lepanto P, Littman P, Mikuta J, Davis L, Celebre J. Treatment of para-aortic nodes in carcinoma of the cervix. Cancer. 1975 Jun;35(6):1510-3. doi: 10.1002/1097-0142(197506)35:63.0.co;2-u.

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• Lovecchio JL, Averette HE, Donato D, Bell J. 5-year survival of patients with periaortic nodal metastases in clinical stage IB and IIA cervical carcinoma. Gynecol Oncol. 1989 Jul;34(1):43-5. doi: 10.1016/0090-8258(89)90103-0.

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• Nori D, Valentine E, Hilaris BS. The role of paraaortic node irradiation in the treatment of cancer of the cervix. Int J Radiat Oncol Biol Phys. 1985 Aug;11(8):1469-73. doi: 10.1016/0360-3016(85)90334-7.

  PMID: 4019270 BACKGROUND

• Tewfik HH, Buchsbaum HJ, Latourette HB, Lifshitz SG, Tewfik FA. Para-aortic lymph node irradiation in carcinoma of the cervix after exploratory laparotomy and biopsy-proven positive aortic nodes. Int J Radiat Oncol Biol Phys. 1982 Jan;8(1):13-8. doi: 10.1016/0360-3016(82)90378-9.

  PMID: 7061247 BACKGROUND

• Grigsby PW, Perez CA, Chao KS, Herzog T, Mutch DG, Rader J. Radiation therapy for carcinoma of the cervix with biopsy-proven positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2001 Mar 1;49(3):733-8. doi: 10.1016/s0360-3016(00)00806-3.

  PMID: 11172956 BACKGROUND

• Rubin SC, Brookland R, Mikuta JJ, Mangan C, Sutton G, Danoff B. Para-aortic nodal metastases in early cervical carcinoma: long-term survival following extended-field radiotherapy. Gynecol Oncol. 1984 Jun;18(2):213-7. doi: 10.1016/0090-8258(84)90028-3.

  PMID: 6735264 BACKGROUND

• Carl UM, Bahnsen J, Wiegel T. Radiation therapy of para-aortic lymph nodes in cancer of the uterine cervix. Acta Oncol. 1993;32(1):63-7. doi: 10.3109/02841869309083887.

  PMID: 8466766 BACKGROUND

• Varia MA, Bundy BN, Deppe G, Mannel R, Averette HE, Rose PG, Connelly P. Cervical carcinoma metastatic to para-aortic nodes: extended field radiation therapy with concomitant 5-fluorouracil and cisplatin chemotherapy: a Gynecologic Oncology Group study. Int J Radiat Oncol Biol Phys. 1998 Dec 1;42(5):1015-23. doi: 10.1016/s0360-3016(98)00267-3.

  PMID: 9869224 BACKGROUND

• Podczaski E, Stryker JA, Kaminski P, Ndubisi B, Larson J, DeGeest K, Sorosky J, Mortel R. Extended-field radiation therapy for carcinoma of the cervix. Cancer. 1990 Jul 15;66(2):251-8. doi: 10.1002/1097-0142(19900715)66:23.0.co;2-e.

  PMID: 2369710 BACKGROUND

• Malfetano JH, Keys H. Aggressive multimodality treatment for cervical cancer with paraaortic lymph node metastases. Gynecol Oncol. 1991 Jul;42(1):44-7. doi: 10.1016/0090-8258(91)90228-w.

  PMID: 1916509 BACKGROUND

• Mutic S, Malyapa RS, Grigsby PW, Dehdashti F, Miller TR, Zoberi I, Bosch WR, Esthappan J, Low DA. PET-guided IMRT for cervical carcinoma with positive para-aortic lymph nodes-a dose-escalation treatment planning study. Int J Radiat Oncol Biol Phys. 2003 Jan 1;55(1):28-35. doi: 10.1016/s0360-3016(02)03804-x.

  PMID: 12504033 BACKGROUND

• Aoki T, Nagata Y, Mizowaki T, Kokubo M, Negoro Y, Takayama K, Mitsumori M, Sasai K, Hiraoka M. Clinical evaluation of dynamic arc conformal radiotherapy for paraaortic lymph node metastasis. Radiother Oncol. 2003 Apr;67(1):113-8. doi: 10.1016/s0167-8140(02)00388-2.

  PMID: 12758247 BACKGROUND

• Wadler S, Goldberg G, Fields A, Anderson P, Beitler JJ, Sood B, Haynes H, Runowicz C. The potential role of amifostine in conjunction with cisplatin in the treatment of locally advanced carcinoma of the cervix. Semin Oncol. 1996 Aug;23(4 Suppl 8):64-8.

  PMID: 8783670 BACKGROUND

• Gallardo D, Mohar A, Calderillo G, Mota A, Solorza G, Lozano A, Solano P, De La Garza J. Cisplatin, radiation, and amifostine in carcinoma of the uterine cervix. Int J Gynecol Cancer. 1999 May;9(3):225-230. doi: 10.1046/j.1525-1438.1999.99029.x.

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• Koukourakis MI, Kyrias G, Kakolyris S, Kouroussis C, Frangiadaki C, Giatromanolaki A, Retalis G, Georgoulias V. Subcutaneous administration of amifostine during fractionated radiotherapy: a randomized phase II study. J Clin Oncol. 2000 Jun;18(11):2226-33. doi: 10.1200/JCO.2000.18.11.2226.

  PMID: 10829042 BACKGROUND

• Athanassiou H, Antonadou D, Coliarakis N, Kouveli A, Synodinou M, Paraskevaidis M, Sarris G, Georgakopoulos GR, Panousaki K, Karageorgis P, Throuvalas N; Oncology Hellenic Group. Protective effect of amifostine during fractionated radiotherapy in patients with pelvic carcinomas: results of a randomized trial. Int J Radiat Oncol Biol Phys. 2003 Jul 15;56(4):1154-60. doi: 10.1016/s0360-3016(03)00187-1.

  PMID: 12829154 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms

Interventions

Radiotherapy; Cisplatin; Amifostine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• Jennifer F De Los Santos, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)