Phase I study of topotecan continuous infusion and weekly cisplatin with radiation therapy for locally advanced/recurrent cervical cancer

Padilla, Luis A.; Mitchell, S.K.; Carson, Linda F.

doi:10.1200/jco.2005.23.16_suppl.5129

Cited by 3 publications

(2 citation statements)

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“…A phase III randomized trial testing this combination for definitive CTRT in stages IIB to IVA disease, has completed accrual but results are not yet available. Similarly, encouraging results have been obtained in phase I studies using cisplatin-combination CTRT with either topotecan or tirapazamine [ 60 - 62 ]. Several phase I/II studies are currently investigating the combination cisplatin-topotecan and GOG trial 0219 is testing the added value of tirapazamine to cisplatin for CTRT in carcinoma of the cervix.…”

Section: Discussionmentioning

confidence: 99%

A phase II randomized trial comparing radiotherapy with concurrent weekly cisplatin or weekly paclitaxel in patients with advanced cervical cancer

et al. 2010

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Purpose/ObjectiveThis is a prospective comparison of weekly cisplatin to weekly paclitaxel as concurrent chemotherapy with standard radiotherapy for locally advanced cervical carcinoma.Materials/MethodsBetween May 2000 and May 2004, 31 women with FIGO stage IB2-IVA cervical cancer or with postsurgical pelvic recurrence were enrolled into this phase II study and randomized to receive on a weekly basis either 40 mg/m2 Cisplatin (group I; 16 patients) or 50 mg/m2 paclitaxel (group II; 15 patients) concurrently with radiotherapy. Median total dose to point A was 74 Gy (range: 66-92 Gy) for group I and 66 Gy (range: 40-98 Gy) for group II. Median follow-up time was 46 months.ResultsPatient and tumor characteristics were similar in both groups. The mean number of chemotherapy cycles was also comparable with 87% and 80% of patients receiving at least 4 doses in groups I and II, respectively. Seven patients (44%) of group I and 8 patients (53%) of group II developed tumor recurrence. The Median Survival time was not reached for Group I and 53 months for group II. The proportion of patients surviving at 2 and 5 years was 78% and 54% for group I and 73% and 43% for group II respectively.ConclusionsThis small prospective study shows that weekly paclitaxel does not provide any clinical advantage over weekly cisplatin for concurrent chemoradiation for advanced carcinoma of the cervix.

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Section: Discussionmentioning

confidence: 99%

A phase II randomized trial comparing radiotherapy with concurrent weekly cisplatin or weekly paclitaxel in patients with advanced cervical cancer

et al. 2010

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“…The continuous infusion of topotecan 0.15 mg/m 2 /d daily for 5 days each week during radiation therapy in combination with cisplatin 20 mg/m 2 weekly was well tolerated and clinically active with a 94% complete response rate and disease free survival at 6 months among stage IB 2 –IVA. 21 One of the more serious adverse events found when using this combination was thromboembolic complications. Some of the other adverse events reported on this trial included lymphopenia, leukopenia, neutropenia, lymphocysts, coagulation difficulties, fatigue, gastrointestinal problems, and non-neutropenic fever.…”

Section: Introductionmentioning

confidence: 99%

A phase I study of concurrent weekly topotecan and cisplatin chemotherapy with whole pelvic radiation therapy in locally advanced cervical cancer: A gynecologic oncology group study

Rose

Sill

McMeekin

et al. 2012

Gynecologic Oncology

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Purpose To determine the maximum tolerated dose (MTD) and acute dose-limiting toxicities (DLT) of intravenous topotecan administered with weekly cisplatin during pelvic radiation therapy in patients with locally advanced cervical cancer. Methods Patients were treated at one of two dose levels receiving intravenous topotecan at 0.5 mg/m2 and cisplatin at either 30 or 40 mg/m2 given weekly for 6 weeks concurrently with pelvic radiation and intracavitary brachytherapy. The primary endpoint for the escalation study was acute dose-limiting toxicities occurring within 30 days of completing radiation therapy. Results Eleven patients were enrolled. Dose-limiting toxicity consisting of Grade 3 nausea and vomiting lasting > 24 hours in one patient and grade 3 febrile neutropenia in another patient occurred at the first dose level of weekly topotecan 0.5 mg/m2 and cisplatin 40 mg/m2. This necessitated de-escalation to weekly cisplatin 30 mg/m2 in combination with topotecan 0.5 mg/m2 and pelvic radiation. This dose level was tolerable in 6 evaluable patients with only one DLT consisting of grade 4 thrombocytopenia, grade 3 abdominal pain and grade 3 elevated gamma glutamyl transpeptidase (GGT). Conclusions In women with locally advanced cervical cancer, intravenous topotecan 0.5 mg/m2 and cisplatin 30 mg/m2 given weekly for 6 weeks with concurrent pelvic radiation and intracavitary brachytherapy was tolerable. Further expansion of the feasibility cohort of this study was suspended based on the results of a phase 3 trial comparing the efficacy of platinum combinations in advanced and recurrent cervical cancer.

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Applications to Gynecological Cancers

Fyles

Milosevic

Oza

2006

Multimodal Concepts for Integration of Cytotoxic Drugs

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Phase I study of topotecan continuous infusion and weekly cisplatin with radiation therapy for locally advanced/recurrent cervical cancer

Cited by 3 publications

References 0 publications

A phase II randomized trial comparing radiotherapy with concurrent weekly cisplatin or weekly paclitaxel in patients with advanced cervical cancer

A phase II randomized trial comparing radiotherapy with concurrent weekly cisplatin or weekly paclitaxel in patients with advanced cervical cancer

A phase I study of concurrent weekly topotecan and cisplatin chemotherapy with whole pelvic radiation therapy in locally advanced cervical cancer: A gynecologic oncology group study

Applications to Gynecological Cancers

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